1,875 Regulatory Affairs Specialist jobs in the United States

No Relocation Assistance Offered
Job Number # - Topeka, Kansas, United States
**Who We Are**
Colgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care, Personal Care, Home Care, Skin Care, and Pet Nutrition. Our products are trusted in more households than any other brand in the world, making us a household name!
Join Colgate-Palmolive, a caring, innovative growth company reimagining a healthier future for people, their pets, and our planet. Guided by our core values-Caring, Inclusive, and Courageous-we foster a culture that inspires our people to achieve common goals. Together, let's build a brighter, healthier future for all.
The Regulatory Affairs Specialist will work to provide support in regulatory related product life-cycle review activities, preparation of regulatory and registry documentation and ensuring compliance with all regulations and statutes during the development, manufacture, and sale of Hill's Pet Nutrition products. They will develop a solid regulatory understanding to provide support and guidance on regulatory requirements, processes and activities for the governance of pet food while collaborating primarily with the Global Regulatory Affairs teams, Science & Technology teams, and the Global Design & Packaging teams. They will also gain general regulatory knowledge and experience that will serve to create an expanded understanding of how Regulatory Affairs supports the business and the regulations around pet food in general. This position supports regulatory related activities including, but not limited to: regulatory intelligence gathering, preparing international regulatory submission documents, creation of copy sheet segmentation, copy content input & review, claims tracker review for segmentation activities, labeling review & approval process for packaging, and product life-cycle activities inclusive of general formula compliance reviews in regards to packaging.
**Principal Duties and Responsibilities**
+ Content Management Tracking.
+ Edits copy upon request (copy alterations) and in compliance with final approved artwork.
+ Reviews, annotates, rejects & approves packaging PDFs for all regions, sizes, types, and styles.
+ Attends relevant project and process meetings as requested.
+ Creates and maintains work instruction documents.
+ Reviews copy content and packaging files/templates for completeness, accuracy, and compliance with regulatory standards.
+ Coordinate with contracted translators for ensuring complete and accurate translations of packaging as well having up to date translations for english masters in the database.
+ Global Change Management Tracking.
+ Build Non-product templates for upcoming projects.
**Required Qualifications:**
+ Bachelor's degree in business, policy, natural sciences or related technical field.
**Preferred Qualifications:**
+ Master's degree in business, policy or in a related technical discipline with a minimum of 1 year of professional work experience.
+ 1-3 years of regulatory experience, preferably with completing official regulatory documentation
+ Pet Food industry experience or a technical background in: Regulatory Science, Quality Assurance, Product Development, Laboratory Sciences, veterinary/animal clinic experience, or similar work experience.
+ Ability to focus on detail while meeting critical timelines
+ Ability to read, speak and write a second language a plus
**Compensation and Benefits**
Salary Range $67,600.00 - $93,000.00 USD
Pay is determined based on experience, qualifications, and location. Salaried employees may also be eligible for discretionary bonuses, profit-sharing, and long-term incentives for Executive-level roles.
Benefits: Salaried employees enjoy a comprehensive benefits package, including medical, dental, vision, basic life insurance, paid parental leave, disability coverage, and participation in the 401(k) retirement plan with company matching contributions subject to eligibility requirements. Additional benefits include a minimum of 15 vacation/PTO days (hourly employees receive a minimum of 120 hours) and 13 paid holidays (vacation days are prorated based on the employee's hire date within the calendar year). Paid sick leave is adjusted based on role and location in accordance with local laws. Detailed information regarding paid sick leave entitlements will be provided to employees upon hiring and may be subject to adjustments based on changes in legislation or company policies.
**Our Commitment to Inclusion**
Our journey begins with our people-developing strong talent with diverse backgrounds and perspectives to best serve our consumers around the world and fostering an inclusive environment where everyone feels a true sense of belonging. We are dedicated to ensuring that each individual can be their authentic self, is treated with respect, and is empowered by leadership to contribute meaningfully to our business.
**Equal Opportunity Employer**
Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, veteran status (United States positions), or any other characteristic protected by law.
Reasonable accommodation during the application process is available for persons with disabilities. Please complete this request form ( should you require accommodation.
For additional Colgate terms and conditions, please click here ( .
#LI-Hybrid

Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Leica Biosystems, one of Danaher's ( 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
At Leica Biosystems, we're not just shaping the future of cancer diagnostics - we're transforming lives. Our mission of "Advancing Cancer Diagnostics, Improving Lives" is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. When you join Leica Biosystems, you're not just taking a job; you're becoming part of a passionate team that knows every moment matters when it comes to cancer. You'll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of next-generation, life-changing therapies. Surrounded by a diverse and collaborative global community, you'll be inspired each day to stretch, grow, and make an impact.
Learn about the Danaher Business System ( which makes everything possible.
The Regulatory Affairs Specialist for Leica Biosystems is responsible for working with cross-functional teams to bring IVD (In-Vitro Diagnostic), Research (RUO) and Laboratorial products to market and support activities related to Quality Management System (QMS) to ensure ongoing compliance while continuing to develop regulatory affairs skills.
This position reports to the Director, Quality Assurance and Regulatory Compliance (Management Representative) and is part of the Regulatory Compliance team located in Richmond, Illinois and will be onsite.
In this role, you will have the opportunity to:
+ Support product registrations, listings, and renewals globally with the support of Leica partners, and directly in US, Canada, and EU markets, requiring cross-functional and cross-site partnership and execution for new products and change management.
+ Support new product development, design change, and sustainment projects by reviewing and approving design files connected to regulatory compliance, using strong problem solving and decision-making skills.
+ Prepare, review, and approve regulatory documentation for submission, including but not limited to Technical Files and DoCs to regulatory agencies or to commercial partners, and advise on the submission strategy.
+ Control new and change legislations related to Regulatory Affairs activities, actively participating in committees and meetings to discuss new guidance including identifying relevant guidance documents, or consensus standards and providing interpretive assistance.
+ Review and approve Advertising and Promotional Materials (MAPSS) to ensure compliance with regulations in country/countries where materials are distributed, and explain complex information and respond to relevant questions raised during audits
The essential requirements of the job include:
+ Bachelor's degree in science, medical, or technical field or equivalent experience.
+ Minimum of two years' experience within medical device/IVD, across a variety of regulatory submissions, compliance initiatives, and cross-functional projects.
+ FDA (Class I & II) and Health Canada regulatory knowledge including registration maintenance, device listings, regulatory requirements, and North America IVD regulatory intelligence.
+ EU (MDR/IVDR) regulatory knowledge including registration maintenance, device listing, regulatory requirements, Importer and Authorized Representative actions.
+ Experience with ISO 13485:2016, IVD/MDR Regulations, FDA GMP and domestic/international Medical Device Regulations.
It would be a plus if you also possess previous experience in:
+ Histopathology / Pathology field
+ Demonstrated strong communication and collaboration skills across technical and non-technical teams
+ Using lean manufacturing tools including Danaher Business Systems (DBS) tools to improve quality, processes, and innovation by applying tools and continuous improvement mind-set
Travel, Motor Vehicle Record & Physical/Environment Requirements:
+ Ability to travel - must be able to travel up to 10% of the time, (domestic and international).
+ Overnight travel may be required.
The annual salary range for this role is between $80,000 - $90,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting.
This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
#LI-LCS
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
The U.S. EEO posters are available here ( .
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: or .

**Job Description Summary**
BD is seeking a Regulatory Affairs Specialist to join our team in Covington, GA. This is a hybrid role with 4 days working at our office. The Regulatory Affairs Specialist is responsible for implementing strategies, including domestic and international submissions, and providing support to product project teams throughout the product life cycle.
**Job Description**
**We are the makers of possible**
BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the creativity and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.
**This is a hybrid role with 4 days working at** **our Covington, GA office**
**Summary**
The Regulatory Affairs Specialist is responsible for implementation of strategies including domestic and international submissions and other support of product project team.
**Requirements**
+ Provide regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control, and preparing submission-related documents)
+ Prepare and audit 510(k)s, IDEs, PMAs, and/or international submissions as required
+ Provide technical collaboration with FDA and international reviewers and respond to questions
+ Provide timely review and approval of product labeling and marketing claims for regulatory compliance
+ Update STED technical files for CE marking activities and notified body interaction to accomplish EU/MDR product
+ May direct Project Team personnel; may provide direction to assistant personnel
**Education**
+ BS in a scientific field with a minimum of six months experience in the areas of medical device product registration, compliance or quality systems; or a combination of education and experience.
+ Regulatory Affairs Certification (RAC) desired
**Compensation**
Competitive compensation package offered, including comprehensive benefits and opportunities for professional growth.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
**Why Join Us?**
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit  Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
Required Skills
Optional Skills
.
**Primary Work Location**
USA GA - Covington BMD
**Additional Locations**
**Work Shift**
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

**Regulatory Affairs Specialist**
Regulatory Affairs
San Fernando Valley, CA, US
Pay Rate Low: 31 | Pay Rate High: 35
+ Added - 03/04/2025
Apply for Job
A leading company in the food and beverage industry is seeking a **Regulatory Affairs Specialist** to ensure compliance with domestic and international regulations. This role involves reviewing technical documentation, managing regulatory data, and supporting product approvals. If you have experience in regulatory affairs and are looking for a dynamic environment, we'd love to hear from you!
**Title:** Regulatory Affairs Specialist III
**Location: San Fernando, CA**
**Pay** : $31-$35/hr
**Contract to hire**
**Key Responsibilities:**
+ Review and manage regulatory documents from suppliers.
+ Ensure products meet U.S. and international compliance standards.
+ Prepare key compliance documents, including allergen, GMO, and ingredient statements.
+ Support product certifications (Halal, Kosher, Organic) and labeling requirements.
+ Assist with safety data sheet (SDS) production and regulatory research.
+ Work closely with internal teams and external partners to maintain compliance.
**Qualifications:**
+ **Education:** Bachelor's degree in Chemistry, Food Science, or a related field.
+ **Experience:** 3-5 years in regulatory affairs, preferably in food and beverage.
+ **Regulatory Knowledge:** Understanding of domestic and international compliance.
+ **Attention to Detail:** Strong analytical and problem-solving skills.
+ **Tech Skills:** Proficiency in MS Office and regulatory databases.
+ **Strong Communicator:** Ability to interpret and explain regulatory requirements clearly.
+ **Time Management:** Capable of managing multiple projects and deadlines
**INDBH**
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

**Regulatory Affairs Specialist**
Clinical
Fort Worth, TX, US
Pay Rate Low: 55 | Pay Rate High: 70
+ Added - 30/05/2025
Apply for Job
Exciting development opportunity to work for a global leader dedicated to helping people see brilliantly. The largest device company in the world - with complementary businesses in Surgical and Vision Care.
**Regulatory Affairs Specialist III**
**Pay rate: DOE**
**1 Year contract position**
+ Supporting EU MDR compliance and lifecycle change management for medical devices.
+ Works closely with site regulatory teams to manage and submit Notified Body (NB) change notifications, maintain regulatory documentation, and support audits and project timelines.
+ Collaborates cross-functionally to ensure timely, high-quality regulatory submissions and supports continuous improvement initiatives.
+ Support the maintenance of Product and QS EC Certificates (MDD /MDR) and associated documentation.
**Key Requirements:**
+ 4+ years in medical device regulatory affairs
+ Experience with European MDR and manufacturing environments
+ Strong background in NB submissions and change management
This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
INDBH
#LI-DNP:
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Job Title: Regulatory Affairs Specialist (Internal Auditing Focused)
Job Description
We are seeking a dedicated and experienced research professional to join our team in a role that involves conducting audits of national cooperative group trials, ensuring compliance with high-risk protocols and potential FDA registration trials. This position is integral to maintaining protocol compliance and enhancing operational efficiency within our organization.
Responsibilities
+ Conduct internal audits of national cooperative group trials, Phase II studies, and high-risk protocols to ensure protocol compliance.
+ Perform new employee enrollment audits focusing on GCP, IRB SOPs, and best practices.
+ Prepare and submit audit reports using standard templates and document findings in the clinical trials management system (CTMS).
+ Maintain expert knowledge of FDA, GCP, ICH, IRB, and institutional regulations.
+ Collaborate with the QAE Program Manager to onboard and train CTO staff on SOPs, IRB policies, GLPs, GCPs, and ICH guidelines.
+ Verify source documentation for selected CRF fields and confirm subject eligibility.
+ Track audits, sponsor monitor letters, and performance reports using OnCore CTMS, CTO Clinical Data Center, and NCI RAVE metrics.
Required Skills & Experience
+ 2+ years' experience as an within internal auditing/regulatory affairs for clinical trials.
+ Bachelors Degree or higher required.
+ Oncology experience highly preferred.
+ Expert knowledge of FDA, GCP, ICH, IRB, and institutional regulations.
Pay and Benefits
The pay range for this position is $33.65 - $36.06/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Charleston,SC.
Application Deadline
This position is anticipated to close on Nov 7, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email (% ) for other accommodation options.

Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting contract opportunity with one of our leading clients!
**Title:** Regulatory Affairs Specialist
**Location:** Cleveland, OH / Beachwood, OH
**Duration:** 12 months +
**Type:** W2 contract **_(NO C2C OR THIRD PARTY)_**
**Pay:** $40.00 - $47.60/hour
**Overview**
+ Join our innovative team in creating the factory of the future for healthcare imaging components.
+ We're dedicated to developing and integrating custom software for manufacturing equipment and data collection, enabling advanced analytics and data-driven insights.
+ Our mission is to enhance product quality and reduce costs through digital solutions.
**Responsibilities**
+ Provides regulatory input for product development to ensure compliance to regulatory requirements for target markets.
+ Develops regulatory strategies to help guide regulatory submission pathways, taking into consideration regulatory requirements (including product testing, clinical data, etc.), product claims and country regulatory dependencies to ensure optimized sequencing for submissions.
+ Works with a cross functional team to prepare and submit regulatory submissions such as 510(k)s, MDR EU Technical Files, or submissions to other global regulators such as NMPA, TGA, etc., for the purpose of obtaining authorization for market launch.
+ Assesses changes in existing products to and determines the need for new / revised licenses or registrations. Develops plan for timely submission of renewal registrations for applicable countries per business plan, to ensure continued product supply in those countries.
+ Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
+ Contributes to writing and editing technical documents.
+ Researches, analyzes, integrates, and organizes background information from diverse sources for regulatory submissions.
+ Ensures compliance with pre- and post-market product approval requirements
+ Supports regulatory inspections, as required.
**Required Qualifications**
+ Bachelor's degree from an accredited university or college, preferred in a Scientific, Engineering, Regulatory, Legal, or core Life Science discipline.
+ Minimum of 4+ years' experience in a highly regulated industry, preferred in Regulatory Affairs, or equivalent experience through advanced degree or other relevant education and experience.
+ Strong verbal and written communication, and presentation skills, with the ability to speak and write clearly and convincingly in English.
+ Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and collaboration applications.
**Preferred Qualifications**
+ Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.
+ Preferably, Regulatory Affairs Certification (RAC) issued by the Regulatory Affairs Professionals Society (RAPS).
+ Experience in medical device regulatory affairs
+ Demonstrated life-long learner; eagerness to obtain new skills and knowledge.
**Additional Information**
+ Hybrid / Monday - Friday / Onsite 3 days a week
+ Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.
**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please contact Taryn Carbone ( ( ) ) for immediate consideration.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® Engineering?
Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.
About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

Regulatory Affairs Specialist
**Date:** Oct 8, 2025
**Location:** Morrisville, NC, US
**Company:** Teleflex
**Expected Travel** : Up to 10%
**Requisition ID** :12601
**About Teleflex Incorporated**
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.
Teleflex is the home of Arrow, Barrigel, Deknatel, QuikClot, LMA, Pilling, Rüsch, UroLift and Weck - trusted brands united by a common sense of purpose.
At Teleflex, we are empowering the future of healthcare. For more information, please visit **teleflex.com** .
**Global Operations -** Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
**Position Summary**
The Regulatory Affairs Specialist will develop strategies and submissions for projects and issues related to regulatory documents, global submissions, investigations, product development planning, and regulatory agency interaction for the Surgical portfolio. Submissions will be moderate to complex and relate to regulatory documents, submissions, investigations, product development planning, and regulatory agency interaction. The incumbent is also responsible for staying abreast of evolving global regulatory requirements.
**Principal Responsibilities**
- Develop regulatory strategies for new products from development to launch for moderate-complexity projects and ensure appropriate data collection for regulatory submissions and compliance.
- Review and assess change control activities for potential impact on current regulatory filings.
- Ensures compliance with design controls, reviews design documentation to ensure that it meets regulatory requirements, and provides regulatory expertise and oversight to design teams.
- Interpret existing regulations and guidance documents within the regulatory department and on project teams. Understand and communicate regulatory requirements and what they mean to the organization and management.
- Identify risk factors and contingency planning for assigned projects.
- Interact with regulatory authorities during the development and review process to ensure submission approval as well as during audits to mitigate any potential risks.
- Interface with FDA, Notified Bodies, or other national health agencies regarding new products and significant product changes as needed.
- Assume full responsibility for project submissions, from guidance/strategies/authoring/obtaining approvals, including 510(k) premarket notifications, EU MDD/MDR Technical Files, and/or other documentation required for registration/licensure of products outside the U.S.
- Develop timelines, coordinate receipt of technical information from appropriate sources, and manage the preparation of responses to regulatory agency questions and/or requests for information.
- Review and approve all Labeling (product, advertising, and promotional) verbiage and evaluate for any regulatory impact.
- Apply understanding of the quality systems to job activities and projects.
- Participate in training RA team members and others on compliance matters.
- Brings Regulatory Affairs questions/issues to the attention of RA management.
- Comply with Teleflex's Code of Ethics, including all company policies, rules, procedures, and housekeeping standards.
#LI-DR1
**Education / Experience Requirements**
- Bachelor's degree in a science or engineering field is preferred.
- 2-3 years of regulatory affairs experience in a regulated environment is required.
- Basic understanding of, or experience with, medical devices with electrical capabilities is a plus.
- Regulatory affairs experience in domestic and international submissions, with 2-3 years of overall class I or II medical devices, is highly preferred.
**Specialized Skills / Other Requirements**
- RAC certification is a plus
- Strong analytical and critical thinking skills
- Strong communication skills (both verbal and technical writing)
- Strong organizational and time management skills with a high level of personal and professional integrity and trustworthiness
- Strong work ethic and the ability to work independently, manage multiple projects with minimal direction, and meet deadlines.
- Orientation to teamwork, problem-solving ability, customer focus, and a commitment to quality
- Knowledge of electronic document management systems
- Basic understanding of, and ability to comply with, business and Regulatory Affairs ethical standards.
- Proficient in MS Word, Excel, PowerPoint, and Outlook required.
#LI-DR1
_At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front._
_Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: or
_Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, QuikClot, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries._
_© 2025 Teleflex Incorporated. All rights reserved._

**Regulatory Affairs Specialist**
Kelly Science and Clinical is seeking a **Regulatory Affairs Specialist** **for** our client a leading medical device company in Bridgewater, NJ. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
**REMOTE**
**Shift:** Monday through Friday day shift
**Length of assignment:** until the end of 2026
**Pay** : $43-47 a hour depending on experience
+ **Responsibilities**
+ Provide support for the execution of the pharmaceutical regulatory strategy and submissions for assigned products: Provide support for IND/NDA/ANDA submission activities as needed, eg., Labeling Supplement, Annual Report, Product Correspondence etc.
+ Support regulatory aspects of product development team to make certain all product documentation is developed in accordance with regulatory requirements for agency filing
+ Participate in product team meetings as needed and complete follow up actions.
+ Support the preparation of documentation and materials required for meetings with Regulatory Authorities for assigned products Manage timely archival of Health Authority Correspondences at company designated location
+ Demonstrated ability in analytical reasoning and critical thinking skills
+ **Qualifications** : Bachelors degree required, in life sciences or health related disciplines preferred. Master s degree preferred
+ 2+ years of relevant pharmaceutical industry and regulatory experience Knowledge of FDA regulations and guidance's
+ Knowledge of pharmaceutical CMC, nonclinical, clinical development to support marketing authorization and/or lifecycle management Ability to partner within regulatory and with cross-functional teams in a pharmaceutical organization
+ Ability to understand scientific information and assess whether technical arguments are articulated clearly
+ Demonstrated ability in analytical reasoning and critical thinking skills
+ Strong capability to contribute to a team environment
+ Excellent communication skills; both oral and written Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
+ **What happens next** Once you apply, you'll proceed to the next steps if your skills and experience look like a good fit. But don't worry-even if this position doesn't work out, you're still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.Helping you discover **what's next** in your career is what we're all about,
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.