1,766 Urology Specialist jobs in the United States

Position: Telemedicine Urologist
Location: Remote
Contract Type: Independent Contractor
Company: MHG

Overview:
MHG is looking for a Urologist to provide remote consultations and treatment plans for urological conditions. This role involves diagnosing and managing issues related to the urinary tract and male reproductive system through telemedicine.

Key Responsibilities:

• Conduct virtual consultations for urological conditions such as urinary tract infections, kidney stones, and prostate issues.
• Develop and manage treatment plans, including medications, lifestyle modifications, and surgical referrals.
• Monitor patient progress and adjust treatments as necessary.
• Review and interpret diagnostic tests, including urine tests and imaging studies.
• Collaborate with other healthcare providers to ensure comprehensive care.
• Maintain accurate and confidential patient records.

Qualifications:

• Medical degree with specialization in Urology.
• Valid medical license and board certification in Urology.
• Experience in telemedicine is preferred.
• Strong diagnostic and communication skills.
• Familiarity with telemedicine platforms and electronic health records.

How to Apply: Interested candidates are invited to submit their resume, cover letter, and relevant certifications. Applications will be reviewed on a rolling basis until the position is filled.

MHG is an equal opportunity employer committed to diversity and inclusion in the workplace. We encourage applications from individuals of all backgrounds and identities.

Best regards,

Maritime & Healthcare Group (MHG)

Child Life Specialist (Urology) at Boston Children's Hospital summary:

The Child Life Specialist in the Department of Urology supports pediatric patients by providing therapeutic activities to address psychosocial and developmental needs, facilitating adjustment to hospital care. This role involves travel between Boston and Waltham hospitals and collaboration with multidisciplinary teams to manage a variety of urologic conditions in children. The position requires a Bachelor's degree in a related field, Child Life certification, and skills in communication, problem-solving, and team collaboration.

Position Summary/ Department Summary:
Please note that travel is required to both our Boston and Waltham hospitals.
Schedule: Hours 8:00am-4:30pm or 8:30am – 5:00pm
Tuesday - Boston
Monday, Wednesday, Thursday and Friday – Waltham

The clinicians in Boston Children’s Department of Urology — ranked among the best in the nation in pediatric urology by U.S. News & World Report — provide expert care for the entire spectrum of urologic conditions. Our team sees infants, children, and adolescents with common urological conditions such as hydronephrosis, urinary reflux, undescended testicles, kidney stones, hypospadias, and urinary incontinence. We also offer deep expertise and a multispecialty approach to more complex urological conditions including bladder exstrophy and epispadias, spina bifida, cloacal deformities, and genitourinary cancers.

Key Responsibilities:
The Child Life Specialist will:

• Participate in therapeutic activities and programs to meet patients' psychosocial and developmental needs, and facilitate adjustment to health care experiences in the intensive care unit
• Serve as member of multidisciplinary team.
• Delegate work assignments to volunteers and participate in clinical training of student interns.
• Work 40 hours per week

• Bachelor's degree in Child Development, Child Life, or a closely related field with a concentration in child life.
• 600-hour Child Life internship under the supervision of a certified child life specialist.

• General skills to resolve problems requiring the use of child development theory, professional child life principles, and experienced‑based knowledge.
• Well-developed writing skills, and excellent communication skills including conflict resolution to effectively work as a team member.

Keywords:

Child Life Specialist, Pediatric Urology, Therapeutic Activities, Psychosocial Support, Child Development, Hospital Care, Multidisciplinary Team, Patient Adjustment, Certified Child Life, Pediatric Healthcare

Job Title: Clinician (LPN/RN)

POSITION SUMMARY:

As a skilled and compassionate clinician, you will work collaboratively with physicians, staff, and other healthcare professionals to provide seamless patient care within the clinic setting.

The nurse is an integral member of the clinic care team who ensures safety, best practices, and high-quality standards of care are maintained across the continuum.

Responsibilities include coordinating various patient wellness and chronic illness activities for the entire patient population, utilizing concepts of critical thinking and creative problem-solving to ensure positive outcomes in clinical care delivery.

Our ideal candidate will have a strong educational foundation in registered nursing, with a preference for a BSN degree. They must be licensed by the State of New Mexico as an RN and hold current BLS certification issued through the American Heart Association.

Required Skills and Qualifications:

• Knowledge of good business principles
• Effective written and verbal communication skills
• Ability to teach effectively using adult learning principles
• Demonstrated ability to coordinate and implement educational materials for patients and their support systems
• One year of experience working as a nurse in a clinical setting

Benefits:

• Opportunity to work in a dynamic and collaborative environment
• Professional growth and development opportunities
• A competitive compensation package

Others:

• Responsible to CSVCG Dyad
• Supervises daily activities of medical assistants
• Ensures timely orientation and competencies completion for all clinical support staff
• Provides feedback to manager for annual performance evaluations of clinical staff
• Frequent exposure to bodily fluids, communicable diseases, toxic substances, ionizing radiation, medicinal preparations, and other conditions common to a clinic environment

Senior Regulatory Affairs Specialist - Urology Work mode : Hybrid Onsite Location(s) : Irvine, CA, US, 92602 Additional Location(s) : US-CA-Irvine; US-CA-Valencia; US-MA-Marlborough; US-MN-Maple Grove Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information, and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing whatever your ambitions. About the role : The Boston Scientific Urology business unit provides proven, leading solutions to treat several common urology diseases, including kidney stones, benign prostatic hyperplasia (BPH), erectile dysfunction (ED), overactive bladder, urinary and fecal incontinence, and pelvic floor disorders. These conditions account for more than 50 percent of all urology surgical procedures. The Senior Regulatory Affairs Specialist is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects, ensuring compliance with FDA regulations, ISO standards, and other regulatory agencies. This position will begin with an onsite onboarding period of approximately 90 to 120 days. Following that, it will transition to a hybrid work model, requiring a minimum of three days per week in the office. The role is ideally based in Irvine, CA, but we are also open to candidates located near our sites in Valencia, CA; Maple Grove, MN; or Marlborough, MA. Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time. Your responsibilities will include : Develops and implements regulatory strategies for new and modified products. Acts as a core team member on sustaining and new product development projects, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, commercialization, and coordinating team inputs for submissions Provides technical guidance and regulatory training / mentoring to other Regulatory Affairs employees and cross-functional teams, monitors proposed and current US and EU regulations and guidance, and advises on the impact of such regulations Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy / regulatory pathway development, testing requirements, clarification and follow-up of submissions under review Reviews and approves design and manufacturing changes for existing products, ensuring compliance with applicable regulations Tracks timelines and documents milestone achievements for inclusion in regulatory submissions Interacts with regulatory agencies as part of submission review and on-site audit support (e.g. IDEs, PMAs, annual reports, 510(k)s, STEDs, and CE marking design dossiers, technical files, and international submissions) Reviews device labeling for compliance with global regulations; analyzes and recommends appropriate changes Trains to departmental and divisional policies and procedures Supports highly technical or major business segment product lines such as combination products, sterilization processes and other special projects or strategic initiatives Fosters a work environment of continuous improvement that supports BSC's Quality Policy, Quality System and the appropriate regulations for their area of responsibility Required qualifications : A minimum of a Bachelor's degree, preferably in a scientific or technical discipline A minimum of 5 years work experience in Regulatory Affairs or a related discipline in medical devices (R&D, Quality, Clinical, Medical Affairs, Biocompatibility) Demonstrated experience of the regulatory requirements associated with implantable or active implantable medical devices Prior experience with PMAs for implantable, active implantable medical devices or other Class III Medical Devices Demonstrated experience supporting product development and sustaining activities for implantable or active implantable medical devices Preferred qualifications : Demonstrated experience of regulations applicable to the conduct of clinical trials Prior experience with regulatory submission writing Demonstrated understanding of product development process and design controls Demonstrated knowledge of FDA, EU and / or international regulations Ability to manage several projects simultaneously Effective research and analytical skills Excellent written and oral communication, technical writing and editing skills Ability to work independently with minimal supervision Strong interpersonal and influencing skills Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Teams, SharePoint, MS Forms) #J-18808-Ljbffr

Additional Location(s): US-CA-Irvine; US-CA-Valencia; US-MA-Marlborough; US-MN-Maple Grove

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance

At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions.

About the role:

The Boston Scientific Urology business unit provides proven, leading solutions to treat several common urology diseases, including kidney stones, benign prostatic hyperplasia (BPH), erectile dysfunction (ED), overactive bladder, urinary and fecal incontinence, and pelvic floor disorders. These conditions account for more than 50 percent of all urology surgical procedures.

The Senior Regulatory Affairs Specialist is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects, ensuring compliance with FDA regulations, ISO standards, and other regulatory agencies.

This position will begin with an onsite onboarding period of approximately 90 to 120 days. Following that, it will transition to a hybrid work model, requiring a minimum of three days per week in the office. The role is ideally based in Irvine, CA, but we are also open to candidates located near our sites in Valencia, CA; Maple Grove, MN; or Marlborough, MA.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time.

Your responsibilities will include:

• Develops and implements regulatory strategies for new and modified products.
• Acts as a core team member on sustaining and new product development projects, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, commercialization, and coordinating team inputs for submissions
• Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams, monitors proposed and current US and EU regulations and guidance, and advises on the impact of such regulations
• Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review
• Reviews and approves design and manufacturing changes for existing products, ensuring compliance with applicable regulations
• Tracks timelines and documents milestone achievements for inclusion in regulatory submissions
• Interacts with regulatory agencies as part of submission review and on-site audit support (e.g. IDEs, PMAs, annual reports, 510(k)s, STEDs, and CE marking design dossiers, technical files, and international submissions)
• Reviews device labeling for compliance with global regulations; analyzes and recommends appropriate changes
• Trains to departmental and divisional policies and procedures
• Supports highly technical or major business segment product lines such as combination products, sterilization processes and other special projects or strategic initiatives
• Fosters a work environment of continuous improvement that supports BSC's Quality Policy, Quality System and the appropriate regulations for their area of responsibility

Required qualifications:

• A minimum of a Bachelor's degree, preferably in a scientific or technical discipline
• A minimum of 5 years work experience in Regulatory Affairs or a related discipline in medical devices (R&D, Quality, Clinical, Medical Affairs, Biocompatibility)
• Demonstrated experience of the regulatory requirements associated with implantable or active implantable medical devices
• Prior experience with PMAs for implantable, active implantable medical devices or other Class III Medical Devices
• Demonstrated experience supporting product development and sustaining activities for implantable or active implantable medical devices

Preferred qualifications:

• Demonstrated experience of regulations applicable to the conduct of clinical trials
• Prior experience with regulatory submission writing
• Demonstrated understanding of product development process and design controls
• Demonstrated knowledge of FDA, EU and/or international regulations
• Ability to manage several projects simultaneously
• Effective research and analytical skills
• Excellent written and oral communication, technical writing and editing skills
• Ability to work independently with minimal supervision
• Strong interpersonal and influencing skillsProficiency with Microsoft Office applications (Word, Excel, PowerPoint, Teams, SharePoint, MS Forms)

#LI-Hybrid

Requisition ID: 608588

Minimum Salary: $86600

Maximum Salary: $164500

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination.

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Onsite Location(s):

Irvine, CA, US, 92602

Additional Location(s): US-CA-Irvine; US-CA-Valencia; US-MA-Marlborough; US-MN-Maple Grove

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance

At Boston Scientific, well give you the opportunity to harness all thats within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, well help you in advancing your skills and career. Here, youll be supported in progressing whatever your ambitions.

About the role:

The Boston Scientific Urology business unit provides proven, leading solutions to treat several common urology diseases, including kidney stones, benign prostatic hyperplasia (BPH), erectile dysfunction (ED), overactive bladder, urinary and fecal incontinence, and pelvic floor disorders. These conditions account for more than 50 percent of all urology surgical procedures.

The Senior Regulatory Affairs Specialist is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects, ensuring compliance with FDA regulations, ISO standards, and other regulatory agencies.

This position will begin with an onsite onboarding period of approximately 90 to 120 days. Following that, it will transition to a hybrid work model, requiring a minimum of three days per week in the office. The role is ideally based in Irvine, CA, but we are also open to candidates located near our sites in Valencia, CA; Maple Grove, MN; or Marlborough, MA.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time.

Your responsibilities will include:

• Develops and implements regulatory strategies for new and modified products.
• Acts as a core team member on sustaining and new product development projects, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, commercialization, and coordinating team inputs for submissions
• Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams, monitors proposed and current US and EU regulations and guidance, and advises on the impact of such regulations
• Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review
• Reviews and approves design and manufacturing changes for existing products, ensuring compliance with applicable regulations
• Tracks timelines and documents milestone achievements for inclusion in regulatory submissions
• Interacts with regulatory agencies as part of submission review and on-site audit support (e.g. IDEs, PMAs, annual reports, 510(k)s, STEDs, and CE marking design dossiers, technical files, and international submissions)
• Reviews device labeling for compliance with global regulations; analyzes and recommends appropriate changes
• Trains to departmental and divisional policies and procedures
• Supports highly technical or major business segment product lines such as combination products, sterilization processes and other special projects or strategic initiatives
• Fosters a work environment of continuous improvement that supports BSCs Quality Policy, Quality System and the appropriate regulations for their area of responsibility

Required qualifications:

• A minimum of a Bachelors degree, preferably in a scientific or technical discipline
• A minimum of 5 years work experience in Regulatory Affairs or a related discipline in medical devices (R&D, Quality, Clinical, Medical Affairs, Biocompatibility)
• Demonstrated experience of the regulatory requirements associated with implantable or active implantable medical devices
• Prior experience with PMAs for implantable, active implantable medical devices or other Class III Medical Devices
• Demonstrated experience supporting product development and sustaining activities for implantable or active implantable medical devices

Preferred qualifications:

• Demonstrated experience of regulations applicable to the conduct of clinical trials
• Prior experience with regulatory submission writing
• Demonstrated understanding of product development process and design controls
• Demonstrated knowledge of FDA, EU and/or international regulations
• Ability to manage several projects simultaneously
• Effective research and analytical skills
• Excellent written and oral communication, technical writing and editing skills
• Ability to work independently with minimal supervision
• Strong interpersonal and influencing skillsProficiency with Microsoft Office applications (Word, Excel, PowerPoint, Teams, SharePoint, MS Forms)

#LI-Hybrid

Requisition ID: 608588

Minimum Salary: $86600

Maximum Salary: $164500

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) see --will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isnt just business, its personal. And if youre a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Companys policies or protocols change with regard to COVID-19 vaccination.

Nearest Major Market: Irvine California
Nearest Secondary Market: Los Angeles
Job Segment: Regulatory Affairs, Compliance, Medical Device, Urology, Law, Legal, Healthcare

Work mode: Hybrid

Onsite Location(s): Irvine, CA, US, 92602

Additional Location(s): US-CA-Irvine; US-CA-Valencia; US-MA-Marlborough; US-MN-Maple Grove

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information, and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing whatever your ambitions.

About the role:

The Boston Scientific Urology business unit provides proven, leading solutions to treat several common urology diseases, including kidney stones, benign prostatic hyperplasia (BPH), erectile dysfunction (ED), overactive bladder, urinary and fecal incontinence, and pelvic floor disorders. These conditions account for more than 50 percent of all urology surgical procedures.

The Senior Regulatory Affairs Specialist is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects, ensuring compliance with FDA regulations, ISO standards, and other regulatory agencies.

This position will begin with an onsite onboarding period of approximately 90 to 120 days. Following that, it will transition to a hybrid work model, requiring a minimum of three days per week in the office. The role is ideally based in Irvine, CA, but we are also open to candidates located near our sites in Valencia, CA; Maple Grove, MN; or Marlborough, MA.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time.

Your responsibilities will include:

• Develops and implements regulatory strategies for new and modified products.
• Acts as a core team member on sustaining and new product development projects, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, commercialization, and coordinating team inputs for submissions
• Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams, monitors proposed and current US and EU regulations and guidance, and advises on the impact of such regulations
• Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review
• Reviews and approves design and manufacturing changes for existing products, ensuring compliance with applicable regulations
• Tracks timelines and documents milestone achievements for inclusion in regulatory submissions
• Interacts with regulatory agencies as part of submission review and on-site audit support (e.g. IDEs, PMAs, annual reports, 510(k)s, STEDs, and CE marking design dossiers, technical files, and international submissions)
• Reviews device labeling for compliance with global regulations; analyzes and recommends appropriate changes
• Trains to departmental and divisional policies and procedures
• Supports highly technical or major business segment product lines such as combination products, sterilization processes and other special projects or strategic initiatives
• Fosters a work environment of continuous improvement that supports BSC's Quality Policy, Quality System and the appropriate regulations for their area of responsibility

Required qualifications:

• A minimum of a Bachelor's degree, preferably in a scientific or technical discipline
• A minimum of 5 years work experience in Regulatory Affairs or a related discipline in medical devices (R&D, Quality, Clinical, Medical Affairs, Biocompatibility)
• Demonstrated experience of the regulatory requirements associated with implantable or active implantable medical devices
• Prior experience with PMAs for implantable, active implantable medical devices or other Class III Medical Devices
• Demonstrated experience supporting product development and sustaining activities for implantable or active implantable medical devices

Preferred qualifications:

• Demonstrated experience of regulations applicable to the conduct of clinical trials
• Prior experience with regulatory submission writing
• Demonstrated understanding of product development process and design controls
• Demonstrated knowledge of FDA, EU and/or international regulations
• Ability to manage several projects simultaneously
• Effective research and analytical skills
• Excellent written and oral communication, technical writing and editing skills
• Ability to work independently with minimal supervision
• Strong interpersonal and influencing skills
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Teams, SharePoint, MS Forms)