1,231 Regulatory Affairs Manager jobs in the United States

Overview:

A growing biopharmaceutical company is seeking a Regulatory Affairs Manager to lead strategic regulatory operations across the U.S., Canada, and other global markets. This is a high-impact leadership role responsible for overseeing regulatory submissions, compliance, and strategy for biologics and medical devices.

Key Responsibilities:

• Lead preparation and submission of regulatory filings (INDs, BLAs, 510(k)s, etc.) in eCTD format
• Manage communications with regulatory agencies including FDA, Health Canada, and USDA
• Oversee promotional and advertising material review and submission
• Provide regulatory guidance on product development and lifecycle management
• Collaborate cross-functionally with Quality, R&D, Manufacturing, and Commercial teams
• Monitor regulatory changes and ensure ongoing compliance
• Lead and mentor the regulatory team, driving performance and professional growth
• Support budgeting and resource planning for the regulatory department

Qualifications:

• 5+ years of regulatory affairs experience in biologics and/or medical devices
• Strong knowledge of FDA, Health Canada, USDA regulations
• Experience with eCTD submissions and promotional review
• Proven leadership and team management experience
• RAC certification preferred
• Bachelor's degree in a scientific discipline required

Why Apply?

This is an opportunity to make a direct impact on regulatory strategy and product success within a mission-driven organization focused on improving patient outcomes through innovative immunotherapy solutions.

Regulatory Affairs Manager (Hybrid Preferred)

Location: Irvine, CA | Full-time | Medical Device Industry

Join a passionate, mission-driven team dedicated to advancing medical device innovation and improving patient outcomes. As a Regulatory Affairs Manager , you will play a key role in coordinating and preparing regulatory submissions, partnering with cross-functional teams, and ensuring compliance with global regulatory standards. This role offers the opportunity to apply your expertise in a collaborative environment while directly contributing to life-saving technologies.

What You’ll Do

• Develop and implement complex, global regulatory strategies for new and modified devices.
• Prepare, review, and submit regulatory documentation for the U.S. and international markets.
• Serve as the regulatory representative on multi-disciplinary project teams, aligning regulatory strategy with business objectives.
• Interact with FDA, Notified Bodies, and international authorities throughout the device lifecycle.
• Review product changes, labeling, advertising, and promotion for compliance with applicable regulations.
• Support ongoing product maintenance, license renewals, and annual registrations.
• Provide regulatory guidance during audits, inspections, and SOP development.
• Consolidate and maintain communication with regulatory agencies and cross-functional stakeholders.

What We’re Looking For

• Bachelor’s degree in a scientific, technical, or related field (advanced degree preferred).
• 5–8 years of regulatory affairs experience in the medical device industry, preferably with Neurovascular or Cardiovascular Devices
• Hands-on experience with U.S. and EU submissions, including HDE, IDE, and PMA applications .
• Strong background in writing, project management, and regulatory coordination.
• Proven experience interfacing with regulatory authorities through all stages of the product lifecycle.
• Ability to thrive in a fast-paced, deadline-driven environment with cross-functional collaboration.
• Proficiency with MS Office and Adobe Acrobat.

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
**The Position**
A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.
At Global Regulatory Affairs our aspiration is to be the world's best Regulatory organization, championing patient access to the world's best diagnostics. Focus of our work is the global approval of in-vitro-diagnostics of the Elecsys immunoassay product portfolio. Our dynamic team manages regulatory projects as well as overarching regulatory topics. Join an open-minded work environment where close collaboration with colleagues across various departments and countries is not just encouraged, but essential.
**The Opportunity**
+ Provide strategic direction and representation of Regulatory Affairs in international and interdisciplinary teams in order to create an impactful and fruitful work environment.
+ Manage neurology, cardiology and core reagents product registrations in the United States, Europe and China and support worldwide registrations.
+ Give regulatory guidance on both strategic and tactical topics to stakeholders and cross-functional project teams of the appropriate customer areas.
+ Prepare and submit premarket submissions to FDA or Notified bodies serving as the primary interface. Interact with regulatory agency personnel in order to expedite approval or clearance of pending registration and answers any questions
+ Be accountable for supporting product care activities and updating the technical documentation of the product portfolio.
+ In order to achieve efficient approvals worldwide, you work in close collaboration with colleagues in Germany, Switzerland and the US within and across chapters as well as with global Regulatory Affairs teams, especially in China and Japan.
**Who You Are**
+ You have a Bachelor's / Master degree in Life Science, Data Science or related subject or equivalent experience. Advanced degree preferred.
+ You have 3-5 years experience with PhD degree, 5-7 with Masters degree and 6-8 years with Bachelor degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent.
+ Technical understanding of medical devices or IVDs
+ In-depth knowledge of immunoassays is highly desirable
+ Knowledge in international laws and regulations for development, manufacturing and registration of IVDs especially in EU, US and China
+ The ability to work independently, reliably, and with exceptional flexibility, allowing you to effectively shift priorities and balance multiple commitments.
+ Proven experience in managing overlapping projects, showcasing your strong ability to juggle multiple tasks, multitask efficiently, and maintain excellent self-organization.
+ A collaborative spirit, recognizing and valuing the contributions of your teammates and peers, and leveraging strong relationships to achieve key results.
**Locations**
You are local to Indianapolis, Indiana, Mannheim or Penzberg Germany. We will consider remote work arrangements under extraordinary circumstances.
*Relocation assistance is not available for this position.*
The expected salary range for this position based on the primary location of Indiana is $104,000-$193,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits ( we are**
A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let's build a healthier future, together.
Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants ( .

Dentsply Sirona is the world's largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona's products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona's global headquarters is located in Charlotte, North Carolina, USA. The company's shares are listed in the United States on NASDAQ under the symbol XRAY.
**Bringing out the best in people**
As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we're looking for the best to join us.
Working at Dentsply Sirona you are able to:
**Develop faster** - with our commitment to the best professional development.
**Perform better** - as part of a high-performance, empowering culture.
**Shape an industry** - with a market leader that continues to drive innovation.
**Make a difference** -by helping improve oral health worldwide.
This position can be a hyrbid working arrangement, for someone that is near any of the following locations: Milford DE, Sarasota FL, Charlotte NC, Johnson City, TN, Waltham, MA, or York, PA
Job Summary:
The primary job responsibility for this position is overseeing the day-to-day functions of the Dentsply Sirona Essential Dental Solutions team. This role develops regulatory strategies for existing, new, and modified medical devices and other (regulated) products. This role manages and submits 510ks for the products and manages communications with FDA including pre-subs. The individual will also be responsible for mentoring and providing guidance to their direct reports and cross-functional product development teams on US and EU regulatory requirements.
This role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance.
Key Responsibilities:
+ Develops and implements regulatory strategies to obtain and maintain regulatory approvals for medical devices and other regulated products globally.
+ Leads and manages regulatory submissions, including 510(k) submissions, and technical files for CE marking.
+ Manages communications with FDA and EU notified bodies on behalf of the company for FDA pre submissions, FDA 510(k) submissions and EU technical files submissions.
+ Provides regulatory guidance and support to cross-functional teams throughout the product lifecycle. Reviews and interprets regulatory requirements and guidance documents to ensure compliance.
+ Coordinates regulatory activities with internal teams and external regulatory agencies.
+ Reviews and approves product labelling and claims for the US and EU markets.
+ Stays current with regulatory requirements and updates affected policies and procedures.
+ Fosters professional interactions with internal and external stakeholders through various communication channels, enhancing business relationships.
+ Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, performance reviews, developmental plans, succession planning.
+ Complies with company and departmental policies and administrative requirements.
+ Performs other duties as assigned or as needed.
Education:
+ Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline.
+ Regulatory Certification (such as RAC from the Regulatory Affairs Professionals Society) or Master's degree in a scientific discipline is a plus.
Years and Type of Experience:
+ 5(+) years of experience in regulatory affairs, preferably in the medical device industry.
+ Experience with leading regulatory submissions and managing regulatory projects.
+ In-depth knowledge of FDA 510(k) and international regulations (e.g., EN ISO 13485, EU MDR).
+ Experience with software as a medical device, AI and/or medical devices containing software is a plus
Required Computer / Software Skills:
+ Proficiency with Microsoft Office Suite
+ Proficiency with Regulatory software
Key Required Skills, Knowledge, and Capabilities:
+ Strong leadership, project management, and organizational skills including attention to detail.
+ Strong written and verbal communication skills.
+ Prior technical writing experience and proven track record with FDA and EU regulatory submissions.
+ Excellent interpersonal skills.
+ Ability to work effectively in a team environment and independently.
+ Knowledge of regulatory affairs principles and practices.
+ Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported.
+ Willingness to learn and adapt to new processes and technologies.
+ Leadership experience within medical device organizations.
Key Leadership Behaviors:
+ Actively articulates and promotes Dentsply Sirona's vision and direction.
+ Advocates on behalf of the customer.
+ Values driven with an insistence on excellence.
+ Promotes high performance, innovation, and continual improvement.
+ Consistently meets Company standards, ethics, and compliance requirements.
+ Strong results orientation and analytical skills.
+ Clear and effective communication with key stakeholders, which span across multiple levels, socio-geographic areas, and functional expertise.
+ Resolves conflicts and fosters a positive working environment.
Dentsply Sirona is an Equal Opportunity/ Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in Dentsply Sirona.
If you need assistance with completing the online application due to a disability, please send an accommodation request to ( ) . Please be sure to include "Accommodation Request" in the subject.

Dentsply Sirona is the world's largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona's products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona's global headquarters is located in Charlotte, North Carolina, USA. The company's shares are listed in the United States on NASDAQ under the symbol XRAY.
**Bringing out the best in people**
As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we're looking for the best to join us.
Working at Dentsply Sirona you are able to:
**Develop faster** - with our commitment to the best professional development.
**Perform better** - as part of a high-performance, empowering culture.
**Shape an industry** - with a market leader that continues to drive innovation.
**Make a difference** -by helping improve oral health worldwide.
This position can be a hyrbid working arrangement, for someone that is near any of the following locations: Milford DE, Sarasota FL, Charlotte NC, Johnson City, TN, Waltham, MA, or York, PA
Job Summary:
The primary job responsibility for this position is overseeing the day-to-day functions of the Dentsply Sirona Essential Dental Solutions team. This role develops regulatory strategies for existing, new, and modified medical devices and other (regulated) products. This role manages and submits 510ks for the products and manages communications with FDA including pre-subs. The individual will also be responsible for mentoring and providing guidance to their direct reports and cross-functional product development teams on US and EU regulatory requirements.
This role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance.
Key Responsibilities:
+ Develops and implements regulatory strategies to obtain and maintain regulatory approvals for medical devices and other regulated products globally.
+ Leads and manages regulatory submissions, including 510(k) submissions, and technical files for CE marking.
+ Manages communications with FDA and EU notified bodies on behalf of the company for FDA pre submissions, FDA 510(k) submissions and EU technical files submissions.
+ Provides regulatory guidance and support to cross-functional teams throughout the product lifecycle. Reviews and interprets regulatory requirements and guidance documents to ensure compliance.
+ Coordinates regulatory activities with internal teams and external regulatory agencies.
+ Reviews and approves product labelling and claims for the US and EU markets.
+ Stays current with regulatory requirements and updates affected policies and procedures.
+ Fosters professional interactions with internal and external stakeholders through various communication channels, enhancing business relationships.
+ Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, performance reviews, developmental plans, succession planning.
+ Complies with company and departmental policies and administrative requirements.
+ Performs other duties as assigned or as needed.
Education:
+ Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline.
+ Regulatory Certification (such as RAC from the Regulatory Affairs Professionals Society) or Master's degree in a scientific discipline is a plus.
Years and Type of Experience:
+ 5(+) years of experience in regulatory affairs, preferably in the medical device industry.
+ Experience with leading regulatory submissions and managing regulatory projects.
+ In-depth knowledge of FDA 510(k) and international regulations (e.g., EN ISO 13485, EU MDR).
+ Experience with software as a medical device, AI and/or medical devices containing software is a plus
Required Computer / Software Skills:
+ Proficiency with Microsoft Office Suite
+ Proficiency with Regulatory software
Key Required Skills, Knowledge, and Capabilities:
+ Strong leadership, project management, and organizational skills including attention to detail.
+ Strong written and verbal communication skills.
+ Prior technical writing experience and proven track record with FDA and EU regulatory submissions.
+ Excellent interpersonal skills.
+ Ability to work effectively in a team environment and independently.
+ Knowledge of regulatory affairs principles and practices.
+ Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported.
+ Willingness to learn and adapt to new processes and technologies.
+ Leadership experience within medical device organizations.
Key Leadership Behaviors:
+ Actively articulates and promotes Dentsply Sirona's vision and direction.
+ Advocates on behalf of the customer.
+ Values driven with an insistence on excellence.
+ Promotes high performance, innovation, and continual improvement.
+ Consistently meets Company standards, ethics, and compliance requirements.
+ Strong results orientation and analytical skills.
+ Clear and effective communication with key stakeholders, which span across multiple levels, socio-geographic areas, and functional expertise.
+ Resolves conflicts and fosters a positive working environment.
Dentsply Sirona is an Equal Opportunity/ Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in Dentsply Sirona.
If you need assistance with completing the online application due to a disability, please send an accommodation request to ( ) . Please be sure to include "Accommodation Request" in the subject.

Dentsply Sirona is the world's largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona's products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona's global headquarters is located in Charlotte, North Carolina, USA. The company's shares are listed in the United States on NASDAQ under the symbol XRAY.
**Bringing out the best in people**
As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we're looking for the best to join us.
Working at Dentsply Sirona you are able to:
**Develop faster** - with our commitment to the best professional development.
**Perform better** - as part of a high-performance, empowering culture.
**Shape an industry** - with a market leader that continues to drive innovation.
**Make a difference** -by helping improve oral health worldwide.
This position can be a hyrbid working arrangement, for someone that is near any of the following locations: Milford DE, Sarasota FL, Charlotte NC, Johnson City, TN, Waltham, MA, or York, PA
Job Summary:
The primary job responsibility for this position is overseeing the day-to-day functions of the Dentsply Sirona Essential Dental Solutions team. This role develops regulatory strategies for existing, new, and modified medical devices and other (regulated) products. This role manages and submits 510ks for the products and manages communications with FDA including pre-subs. The individual will also be responsible for mentoring and providing guidance to their direct reports and cross-functional product development teams on US and EU regulatory requirements.
This role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance.
Key Responsibilities:
+ Develops and implements regulatory strategies to obtain and maintain regulatory approvals for medical devices and other regulated products globally.
+ Leads and manages regulatory submissions, including 510(k) submissions, and technical files for CE marking.
+ Manages communications with FDA and EU notified bodies on behalf of the company for FDA pre submissions, FDA 510(k) submissions and EU technical files submissions.
+ Provides regulatory guidance and support to cross-functional teams throughout the product lifecycle. Reviews and interprets regulatory requirements and guidance documents to ensure compliance.
+ Coordinates regulatory activities with internal teams and external regulatory agencies.
+ Reviews and approves product labelling and claims for the US and EU markets.
+ Stays current with regulatory requirements and updates affected policies and procedures.
+ Fosters professional interactions with internal and external stakeholders through various communication channels, enhancing business relationships.
+ Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, performance reviews, developmental plans, succession planning.
+ Complies with company and departmental policies and administrative requirements.
+ Performs other duties as assigned or as needed.
Education:
+ Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline.
+ Regulatory Certification (such as RAC from the Regulatory Affairs Professionals Society) or Master's degree in a scientific discipline is a plus.
Years and Type of Experience:
+ 5(+) years of experience in regulatory affairs, preferably in the medical device industry.
+ Experience with leading regulatory submissions and managing regulatory projects.
+ In-depth knowledge of FDA 510(k) and international regulations (e.g., EN ISO 13485, EU MDR).
+ Experience with software as a medical device, AI and/or medical devices containing software is a plus
Required Computer / Software Skills:
+ Proficiency with Microsoft Office Suite
+ Proficiency with Regulatory software
Key Required Skills, Knowledge, and Capabilities:
+ Strong leadership, project management, and organizational skills including attention to detail.
+ Strong written and verbal communication skills.
+ Prior technical writing experience and proven track record with FDA and EU regulatory submissions.
+ Excellent interpersonal skills.
+ Ability to work effectively in a team environment and independently.
+ Knowledge of regulatory affairs principles and practices.
+ Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported.
+ Willingness to learn and adapt to new processes and technologies.
+ Leadership experience within medical device organizations.
Key Leadership Behaviors:
+ Actively articulates and promotes Dentsply Sirona's vision and direction.
+ Advocates on behalf of the customer.
+ Values driven with an insistence on excellence.
+ Promotes high performance, innovation, and continual improvement.
+ Consistently meets Company standards, ethics, and compliance requirements.
+ Strong results orientation and analytical skills.
+ Clear and effective communication with key stakeholders, which span across multiple levels, socio-geographic areas, and functional expertise.
+ Resolves conflicts and fosters a positive working environment.
Dentsply Sirona is an Equal Opportunity/ Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in Dentsply Sirona.
If you need assistance with completing the online application due to a disability, please send an accommodation request to ( ) . Please be sure to include "Accommodation Request" in the subject.

Dentsply Sirona is the world's largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona's products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona's global headquarters is located in Charlotte, North Carolina, USA. The company's shares are listed in the United States on NASDAQ under the symbol XRAY.
**Bringing out the best in people**
As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we're looking for the best to join us.
Working at Dentsply Sirona you are able to:
**Develop faster** - with our commitment to the best professional development.
**Perform better** - as part of a high-performance, empowering culture.
**Shape an industry** - with a market leader that continues to drive innovation.
**Make a difference** -by helping improve oral health worldwide.
This position can be a hyrbid working arrangement, for someone that is near any of the following locations: Milford DE, Sarasota FL, Charlotte NC, Johnson City, TN, Waltham, MA, or York, PA
Job Summary:
The primary job responsibility for this position is overseeing the day-to-day functions of the Dentsply Sirona Essential Dental Solutions team. This role develops regulatory strategies for existing, new, and modified medical devices and other (regulated) products. This role manages and submits 510ks for the products and manages communications with FDA including pre-subs. The individual will also be responsible for mentoring and providing guidance to their direct reports and cross-functional product development teams on US and EU regulatory requirements.
This role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance.
Key Responsibilities:
+ Develops and implements regulatory strategies to obtain and maintain regulatory approvals for medical devices and other regulated products globally.
+ Leads and manages regulatory submissions, including 510(k) submissions, and technical files for CE marking.
+ Manages communications with FDA and EU notified bodies on behalf of the company for FDA pre submissions, FDA 510(k) submissions and EU technical files submissions.
+ Provides regulatory guidance and support to cross-functional teams throughout the product lifecycle. Reviews and interprets regulatory requirements and guidance documents to ensure compliance.
+ Coordinates regulatory activities with internal teams and external regulatory agencies.
+ Reviews and approves product labelling and claims for the US and EU markets.
+ Stays current with regulatory requirements and updates affected policies and procedures.
+ Fosters professional interactions with internal and external stakeholders through various communication channels, enhancing business relationships.
+ Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, performance reviews, developmental plans, succession planning.
+ Complies with company and departmental policies and administrative requirements.
+ Performs other duties as assigned or as needed.
Education:
+ Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline.
+ Regulatory Certification (such as RAC from the Regulatory Affairs Professionals Society) or Master's degree in a scientific discipline is a plus.
Years and Type of Experience:
+ 5(+) years of experience in regulatory affairs, preferably in the medical device industry.
+ Experience with leading regulatory submissions and managing regulatory projects.
+ In-depth knowledge of FDA 510(k) and international regulations (e.g., EN ISO 13485, EU MDR).
+ Experience with software as a medical device, AI and/or medical devices containing software is a plus
Required Computer / Software Skills:
+ Proficiency with Microsoft Office Suite
+ Proficiency with Regulatory software
Key Required Skills, Knowledge, and Capabilities:
+ Strong leadership, project management, and organizational skills including attention to detail.
+ Strong written and verbal communication skills.
+ Prior technical writing experience and proven track record with FDA and EU regulatory submissions.
+ Excellent interpersonal skills.
+ Ability to work effectively in a team environment and independently.
+ Knowledge of regulatory affairs principles and practices.
+ Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported.
+ Willingness to learn and adapt to new processes and technologies.
+ Leadership experience within medical device organizations.
Key Leadership Behaviors:
+ Actively articulates and promotes Dentsply Sirona's vision and direction.
+ Advocates on behalf of the customer.
+ Values driven with an insistence on excellence.
+ Promotes high performance, innovation, and continual improvement.
+ Consistently meets Company standards, ethics, and compliance requirements.
+ Strong results orientation and analytical skills.
+ Clear and effective communication with key stakeholders, which span across multiple levels, socio-geographic areas, and functional expertise.
+ Resolves conflicts and fosters a positive working environment.
Dentsply Sirona is an Equal Opportunity/ Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in Dentsply Sirona.
If you need assistance with completing the online application due to a disability, please send an accommodation request to ( ) . Please be sure to include "Accommodation Request" in the subject.

Dentsply Sirona is the world's largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona's products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona's global headquarters is located in Charlotte, North Carolina, USA. The company's shares are listed in the United States on NASDAQ under the symbol XRAY.
**Bringing out the best in people**
As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we're looking for the best to join us.
Working at Dentsply Sirona you are able to:
**Develop faster** - with our commitment to the best professional development.
**Perform better** - as part of a high-performance, empowering culture.
**Shape an industry** - with a market leader that continues to drive innovation.
**Make a difference** -by helping improve oral health worldwide.
This position can be a hyrbid working arrangement, for someone that is near any of the following locations: Milford DE, Sarasota FL, Charlotte NC, Johnson City, TN, Waltham, MA, or York, PA
Job Summary:
The primary job responsibility for this position is overseeing the day-to-day functions of the Dentsply Sirona Essential Dental Solutions team. This role develops regulatory strategies for existing, new, and modified medical devices and other (regulated) products. This role manages and submits 510ks for the products and manages communications with FDA including pre-subs. The individual will also be responsible for mentoring and providing guidance to their direct reports and cross-functional product development teams on US and EU regulatory requirements.
This role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance.
Key Responsibilities:
+ Develops and implements regulatory strategies to obtain and maintain regulatory approvals for medical devices and other regulated products globally.
+ Leads and manages regulatory submissions, including 510(k) submissions, and technical files for CE marking.
+ Manages communications with FDA and EU notified bodies on behalf of the company for FDA pre submissions, FDA 510(k) submissions and EU technical files submissions.
+ Provides regulatory guidance and support to cross-functional teams throughout the product lifecycle. Reviews and interprets regulatory requirements and guidance documents to ensure compliance.
+ Coordinates regulatory activities with internal teams and external regulatory agencies.
+ Reviews and approves product labelling and claims for the US and EU markets.
+ Stays current with regulatory requirements and updates affected policies and procedures.
+ Fosters professional interactions with internal and external stakeholders through various communication channels, enhancing business relationships.
+ Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, performance reviews, developmental plans, succession planning.
+ Complies with company and departmental policies and administrative requirements.
+ Performs other duties as assigned or as needed.
Education:
+ Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline.
+ Regulatory Certification (such as RAC from the Regulatory Affairs Professionals Society) or Master's degree in a scientific discipline is a plus.
Years and Type of Experience:
+ 5(+) years of experience in regulatory affairs, preferably in the medical device industry.
+ Experience with leading regulatory submissions and managing regulatory projects.
+ In-depth knowledge of FDA 510(k) and international regulations (e.g., EN ISO 13485, EU MDR).
+ Experience with software as a medical device, AI and/or medical devices containing software is a plus
Required Computer / Software Skills:
+ Proficiency with Microsoft Office Suite
+ Proficiency with Regulatory software
Key Required Skills, Knowledge, and Capabilities:
+ Strong leadership, project management, and organizational skills including attention to detail.
+ Strong written and verbal communication skills.
+ Prior technical writing experience and proven track record with FDA and EU regulatory submissions.
+ Excellent interpersonal skills.
+ Ability to work effectively in a team environment and independently.
+ Knowledge of regulatory affairs principles and practices.
+ Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported.
+ Willingness to learn and adapt to new processes and technologies.
+ Leadership experience within medical device organizations.
Key Leadership Behaviors:
+ Actively articulates and promotes Dentsply Sirona's vision and direction.
+ Advocates on behalf of the customer.
+ Values driven with an insistence on excellence.
+ Promotes high performance, innovation, and continual improvement.
+ Consistently meets Company standards, ethics, and compliance requirements.
+ Strong results orientation and analytical skills.
+ Clear and effective communication with key stakeholders, which span across multiple levels, socio-geographic areas, and functional expertise.
+ Resolves conflicts and fosters a positive working environment.
Dentsply Sirona is an Equal Opportunity/ Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in Dentsply Sirona.
If you need assistance with completing the online application due to a disability, please send an accommodation request to ( ) . Please be sure to include "Accommodation Request" in the subject.

Dentsply Sirona is the world's largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona's products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona's global headquarters is located in Charlotte, North Carolina, USA. The company's shares are listed in the United States on NASDAQ under the symbol XRAY.
**Bringing out the best in people**
As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we're looking for the best to join us.
Working at Dentsply Sirona you are able to:
**Develop faster** - with our commitment to the best professional development.
**Perform better** - as part of a high-performance, empowering culture.
**Shape an industry** - with a market leader that continues to drive innovation.
**Make a difference** -by helping improve oral health worldwide.
This position can be a hyrbid working arrangement, for someone that is near any of the following locations: Milford DE, Sarasota FL, Charlotte NC, Johnson City, TN, Waltham, MA, or York, PA
Job Summary:
The primary job responsibility for this position is overseeing the day-to-day functions of the Dentsply Sirona Essential Dental Solutions team. This role develops regulatory strategies for existing, new, and modified medical devices and other (regulated) products. This role manages and submits 510ks for the products and manages communications with FDA including pre-subs. The individual will also be responsible for mentoring and providing guidance to their direct reports and cross-functional product development teams on US and EU regulatory requirements.
This role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance.
Key Responsibilities:
+ Develops and implements regulatory strategies to obtain and maintain regulatory approvals for medical devices and other regulated products globally.
+ Leads and manages regulatory submissions, including 510(k) submissions, and technical files for CE marking.
+ Manages communications with FDA and EU notified bodies on behalf of the company for FDA pre submissions, FDA 510(k) submissions and EU technical files submissions.
+ Provides regulatory guidance and support to cross-functional teams throughout the product lifecycle. Reviews and interprets regulatory requirements and guidance documents to ensure compliance.
+ Coordinates regulatory activities with internal teams and external regulatory agencies.
+ Reviews and approves product labelling and claims for the US and EU markets.
+ Stays current with regulatory requirements and updates affected policies and procedures.
+ Fosters professional interactions with internal and external stakeholders through various communication channels, enhancing business relationships.
+ Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, performance reviews, developmental plans, succession planning.
+ Complies with company and departmental policies and administrative requirements.
+ Performs other duties as assigned or as needed.
Education:
+ Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline.
+ Regulatory Certification (such as RAC from the Regulatory Affairs Professionals Society) or Master's degree in a scientific discipline is a plus.
Years and Type of Experience:
+ 5(+) years of experience in regulatory affairs, preferably in the medical device industry.
+ Experience with leading regulatory submissions and managing regulatory projects.
+ In-depth knowledge of FDA 510(k) and international regulations (e.g., EN ISO 13485, EU MDR).
+ Experience with software as a medical device, AI and/or medical devices containing software is a plus
Required Computer / Software Skills:
+ Proficiency with Microsoft Office Suite
+ Proficiency with Regulatory software
Key Required Skills, Knowledge, and Capabilities:
+ Strong leadership, project management, and organizational skills including attention to detail.
+ Strong written and verbal communication skills.
+ Prior technical writing experience and proven track record with FDA and EU regulatory submissions.
+ Excellent interpersonal skills.
+ Ability to work effectively in a team environment and independently.
+ Knowledge of regulatory affairs principles and practices.
+ Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported.
+ Willingness to learn and adapt to new processes and technologies.
+ Leadership experience within medical device organizations.
Key Leadership Behaviors:
+ Actively articulates and promotes Dentsply Sirona's vision and direction.
+ Advocates on behalf of the customer.
+ Values driven with an insistence on excellence.
+ Promotes high performance, innovation, and continual improvement.
+ Consistently meets Company standards, ethics, and compliance requirements.
+ Strong results orientation and analytical skills.
+ Clear and effective communication with key stakeholders, which span across multiple levels, socio-geographic areas, and functional expertise.
+ Resolves conflicts and fosters a positive working environment.
Dentsply Sirona is an Equal Opportunity/ Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in Dentsply Sirona.
If you need assistance with completing the online application due to a disability, please send an accommodation request to ( ) . Please be sure to include "Accommodation Request" in the subject.