Principal Regulatory Affairs Specialist Jobs
Principal Regulatory Affairs Specialist jobs are open across pharmaceutical, medical device, biotechnology, and consumer products industries, from mid-level to principal and director, with specializations in drug submissions, FDA strategy, and combination products. Find a role that fits below and apply directly.
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Showing 5 of 26+ Principal Regulatory Affairs Specialist jobs
Job Summary
Responsible for developing regulatory strategies for global approvals that introduce new products to market and maintain existing products. The position is responsible for negotiating with regulatory authorities, and inform future product development. This position must function independently to resolve regulatory issues, provide direction on projects of large scale with significant business impact, negotiate with regulatory authorities, and inform ongoing project and product development. The Regulatory Specialist Principal leads work groups as a recognized expert in various and diverse area(s) of regulatory and technical competency.Job Description
MAJOR RESPONSIBILITIES:
- In support of business priorities, determine the requirements for completing and maintaining product submissions and regulatory filings for clearance/approval in assigned market(s), including for national or multi-national launch projects. Identify and pro-vide solutions for factors that could impact the success or viability of new product launch in assigned market(s). Monitor changes in regulations that impact current or future requirements and overall compliance; actively propose and execute necessary changes to impacted procedures, products, or records. Acquire and apply knowledge of harmonized standards where applicable.
- Communicate requirements of regulations to internal or external customers. Recommend regulatory pathways, strategies, solutions, and future actions for specific and diverse scenarios, accounting for business objectives and factors relevant to other departments/functional areas.
- Review and provide direction to ensure supporting evidence meets appropriate regulatory requirements. Assess records against multiple requirements sources, including regulations, guidance documents, and standards utilized in various applicable markets that have been identified as applicable.
- Direct and take action to complete and maintain regulatory filings by leading internal groups, collaborating with external groups, providing direction to obtain sup-porting technical information, and implementing focused solutions for identified changes and challenges. Lead direct communication with critical regulators to respond to non-conformances and questions.
- Lead processes and projects involving the development, review, and substantiation of product labeling and claims where needed for various markets and projects.
- Manage complex projects by providing direction on diverse regulatory pathways, defining timelines for technical deliverables and multifaceted project teams, identifying and correcting process deficiencies, and de-fining future actions and solutions.
- Proactively review, improve, and develop regulatory-driven and technical processes.
- Propose, establish, and maintain department databases, logs, and files necessary for ensuring ongoing compliance. Oversee and lead internal and external au-dits and manage post-audit corrective actions.
MINIMUM JOB REQUIREMENTS:
Education:
- B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related.
Work Experience:
- Strong global background (5+ years) of di-verse regulatory experience in the medical device industry, including support of pre- and post-market regulatory activities, independent submissions, participating in regulatory intelligence programs, and development and implementation of regulatory strategies in multiple international markets. Sound background and ability to lead efforts related to technical fields such as risk management and design and development. Extensive experience authoring and sub-mitting regulatory submissions including 510(k)s and CE Technical Files. Extensive experience communicating and negotiating with regulatory agencies, including FDA and notified bodies.
Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
The anticipated salary range for this position:
$116,000.00 - $174,000.00 AnnualThe actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here .
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
Job Summary
Responsible for developing regulatory strategies for global approvals that introduce new products to market and maintain existing products. The position is responsible for negotiating with regulatory authorities, and inform future product development. This position must function independently to resolve regulatory issues, provide direction on projects of large scale with significant business impact, negotiate with regulatory authorities, and inform ongoing project and product development. The Regulatory Specialist Principal leads work groups as a recognized expert in various and diverse area(s) of regulatory and technical competency.Job Description
MAJOR RESPONSIBILITIES:
- In support of business priorities, determine the requirements for completing and maintaining product submissions and regulatory filings for clearance/approval in assigned market(s), including for national or multi-national launch projects. Identify and pro-vide solutions for factors that could impact the success or viability of new product launch in assigned market(s). Monitor changes in regulations that impact current or future requirements and overall compliance; actively propose and execute necessary changes to impacted procedures, products, or records. Acquire and apply knowledge of harmonized standards where applicable.
- Communicate requirements of regulations to internal or external customers. Recommend regulatory pathways, strategies, solutions, and future actions for specific and diverse scenarios, accounting for business objectives and factors relevant to other departments/functional areas.
- Review and provide direction to ensure supporting evidence meets appropriate regulatory requirements. Assess records against multiple requirements sources, including regulations, guidance documents, and standards utilized in various applicable markets that have been identified as applicable.
- Direct and take action to complete and maintain regulatory filings by leading internal groups, collaborating with external groups, providing direction to obtain sup-porting technical information, and implementing focused solutions for identified changes and challenges. Lead direct communication with critical regulators to respond to non-conformances and questions.
- Lead processes and projects involving the development, review, and substantiation of product labeling and claims where needed for various markets and projects.
- Manage complex projects by providing direction on diverse regulatory pathways, defining timelines for technical deliverables and multifaceted project teams, identifying and correcting process deficiencies, and de-fining future actions and solutions.
- Proactively review, improve, and develop regulatory-driven and technical processes.
- Propose, establish, and maintain department databases, logs, and files necessary for ensuring ongoing compliance. Oversee and lead internal and external au-dits and manage post-audit corrective actions.
MINIMUM JOB REQUIREMENTS:
Education:
- B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related.
Work Experience:
- Strong global background (5+ years) of di-verse regulatory experience in the medical device industry, including support of pre- and post-market regulatory activities, independent submissions, participating in regulatory intelligence programs, and development and implementation of regulatory strategies in multiple international markets. Sound background and ability to lead efforts related to technical fields such as risk management and design and development. Extensive experience authoring and sub-mitting regulatory submissions including 510(k)s and CE Technical Files. Extensive experience communicating and negotiating with regulatory agencies, including FDA and notified bodies.
Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
The anticipated salary range for this position:
$116,000.00 - $174,000.00 AnnualThe actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here .
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
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Find JobsPrincipal Regulatory Affairs Specialist Job Market
Who's Hiring
Top Industries Hiring
- Biotechnology & Pharmaceuticals
What Employers Look For
The qualifications that appear most often in principal regulatory affairs specialist jobs.
- Bachelor's or advanced degree in life sciences, pharmacy, chemistry, or a related field
- Extensive experience managing FDA submissions including INDs, NDAs, BLAs, or 510(k)s
- Demonstrated ability to lead regulatory strategy for product development programs
- Proficiency with electronic submission systems such as eCTD publishing tools
- Regulatory Affairs Certification (RAC) from RAPS strongly preferred
- Experience interpreting and applying CFR, ICH guidelines, and relevant FDA guidance documents
Tips for Your Principal Regulatory Affairs Specialist Job Search
Tailor your resume to submission types
Highlight the specific submission types you've led, whether INDs, NDAs, BLAs, 510(k)s, or PMAs. Hiring managers scan for exact regulatory pathway experience, so a generic summary will cost you interviews that a targeted one would win.
List every agency and territory you know
Principal-level roles often require cross-jurisdictional fluency. Call out your experience with FDA, EMA, Health Canada, or PMDA explicitly on your resume so recruiters aren't left guessing about your geographic scope.
Apply early to roles that fit
Migrate Mate lists principal regulatory affairs specialist openings from across the United States in one place, so you can find roles that match and apply directly to each listing.
Search by product classification first
Filter openings by product type before job title. A principal specialist role at a biologics company requires a very different background than one at a Class III device firm, and targeting by product category gets your application in front of the right hiring team.
Prepare a submission timeline story
Interviewers at the principal level expect you to walk through a complex submission from kick-off to approval, including how you resolved agency feedback. Practice a concise two-minute version that covers your decision-making, not just the outcome.
Negotiate scope before you negotiate salary
At the principal level, your ability to influence regulatory strategy is often more negotiable than the title itself. Clarify during offer discussions whether you'll own agency interactions directly or sit behind a manager, since that scope difference shapes your career trajectory.
Principal Regulatory Affairs Specialist Jobs: Frequently Asked Questions
Which companies are hiring the most principal regulatory affairs specialists?
The companies hiring the most principal regulatory affairs specialists right now include Werfen, Boston Scientific, and Bracco Medical Technologies, with the largest share of openings in California, Massachusetts, and Minnesota, based on current listings on Migrate Mate as of November 2026. Pharmaceutical companies and large medical device manufacturers consistently account for the majority of principal-level postings.
How many principal regulatory affairs specialist jobs are remote?
About 73% of principal regulatory affairs specialist openings are fully remote or hybrid as of November 2026, reflecting broad adoption of flexible work in the regulatory function. Roles focused on submissions management and regulatory writing tend to be the most remote-friendly, while positions requiring direct lab access or frequent agency interactions are more likely to require on-site presence.
How do you become a principal regulatory affairs specialist?
Start with a degree in a life science, pharmacy, or engineering field, then build several years of hands-on experience in regulatory affairs at a pharmaceutical, biotechnology, or medical device company. Progress through associate and specialist roles while taking on increasingly complex submissions and agency interactions. Earning an RAC credential demonstrates professional commitment. Principal-level roles typically require a proven record of leading submissions independently and contributing to regulatory strategy.
Can you get hired as a principal regulatory affairs specialist without direct regulatory experience?
Moving directly into a principal role without prior regulatory affairs experience is uncommon because the title signals deep submission and strategy expertise. That said, candidates with strong adjacent backgrounds in clinical affairs, quality assurance, or pharmaceutical sciences can bridge in by emphasizing regulatory-adjacent work, such as writing clinical study protocols or managing quality management system documentation. Lateral entry at a specialist level first is a more realistic starting point.
What does the principal regulatory affairs specialist interview process look like?
The process typically begins with a recruiter screen focused on submission history and product types, followed by a technical interview with the regulatory team where you'll walk through past submissions and explain strategic decisions. A panel interview with cross-functional stakeholders from R&D, quality, and clinical is common at the principal level. Some employers include a written case study asking you to outline a regulatory strategy for a hypothetical product scenario.
Where can I find and apply to principal regulatory affairs specialist jobs?
You can find and apply to principal regulatory affairs specialist jobs on Migrate Mate, which lists current openings from across the United States. Find roles that match your submission background and product expertise, then apply directly to each listing that fits.
See All 26 Principal Regulatory Affairs Specialist Jobs
Find roles that match your experience and apply in just a few clicks.
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