Regulatory Affairs Specialist Jobs
Regulatory Affairs Specialist jobs are open across pharmaceuticals, medical devices, biotechnology, and consumer products, from entry-level associate to principal and director, with specializations in drug submissions, FDA compliance, and post-market surveillance. Find a role that fits from the openings below and apply directly.
Find JobsOverview
Showing 5 of 78+ Regulatory Affairs Specialist jobs
INTRODUCTION
As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.
We are the people who give possibilities purpose
JOB DESCRIPTION
The Regulatory Affairs Specialist (Innovation) is responsible for providing regulatory guidance, developing regulatory strategies, and conducting risk assessments, to new product development (NPD) teams for in vitro diagnostic (IVD) products. This position will be responsible for preparing FDA submissions, including, but not limited to: Pre-IDEs, PMA, PMA Supplements, De Novo Petitions, 510(k) submissions, and CLIA Waiver applications, as well as EU IVDR Technical Files/Dossiers.
Responsibilities:
- Serves as Regulatory Affairs SME on various new product development (NPD) teams
- Works cross-functionally with R&D, Medical Affairs, Quality, Marketing, Program Management and other key organizational functions
- Recognizes and addresses potential regulatory risks with project plans
- Responsible for organizing and leading various FDA & EU IVDR submissions
- Serves as contact to FDA and Notified Body review teams during submission reviews/communication
- Recognizes and proposes continuous process improvements.
Required Education and Experience:
Bachelor’s degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, Pharmacy, or related scientific/technical discipline (Equivalent combination of education and relevant experience may be considered)
Minimum 5 years of directly related regulatory experience in the in vitro diagnostic device and/or medical device area(s)
Preferred Skills and Experience:
- RAPS Certification preferred
- Demonstrated experience in interpreting subjective and complex aspects of specific regulations
- Demonstrates in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes
- Demonstrated success in supporting product development and product support projects, including complex projects involving ambiguity and rapid change
- Demonstrated success in preparing, filing and/or completing (including negotiations) regulatory submissions
Skills
- Ability to analyze complex issues and to formulate sound approaches to resolving/addressing issues
- Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices
- Ability to handle multiple tasks and to prioritize and schedule work to meet business needs. Minimal supervision required.
Technical & Functional:
- Experience coordinating cross-functional inputs (i.e. R&D, Quality, Medical Affairs, Program Management, Marketing)
- Ability to compile and review documentation to support FDA submissions and EU IVDR documentation
- Understanding of regulatory submission processes and lifecycle management
Communication & Collaboration:
- Strong written and verbal communication skills
- Experience working with cross-functional, fast-moving teams
- Confidence in speaking up within cross-functional teams when regulatory risks are present
Process & Compliance:
- Familiarity with SOPs, regulatory procedures, and quality systems (e.g., ISO 13485)
- Ability to identify and support process improvements
Other:
- Strong organizational skills and ability to manage multiple submissions/projects simultaneously
- Adaptability to changing timelines and priorities
- Proficiency in Microsoft Office tools (Excel, Word, PowerPoint)
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.
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?
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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
LOCATION
Location
Sparks, Maryland
WORK SHIFT
At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."
Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.
Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
SALARY RANGE INFORMATION
$95,900.00 - $153,400.00 USD Annual
Becton, 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.
INTRODUCTION
As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.
We are the people who give possibilities purpose
JOB DESCRIPTION
The Regulatory Affairs Specialist (Innovation) is responsible for providing regulatory guidance, developing regulatory strategies, and conducting risk assessments, to new product development (NPD) teams for in vitro diagnostic (IVD) products. This position will be responsible for preparing FDA submissions, including, but not limited to: Pre-IDEs, PMA, PMA Supplements, De Novo Petitions, 510(k) submissions, and CLIA Waiver applications, as well as EU IVDR Technical Files/Dossiers.
Responsibilities:
- Serves as Regulatory Affairs SME on various new product development (NPD) teams
- Works cross-functionally with R&D, Medical Affairs, Quality, Marketing, Program Management and other key organizational functions
- Recognizes and addresses potential regulatory risks with project plans
- Responsible for organizing and leading various FDA & EU IVDR submissions
- Serves as contact to FDA and Notified Body review teams during submission reviews/communication
- Recognizes and proposes continuous process improvements.
Required Education and Experience:
Bachelor’s degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, Pharmacy, or related scientific/technical discipline (Equivalent combination of education and relevant experience may be considered)
Minimum 5 years of directly related regulatory experience in the in vitro diagnostic device and/or medical device area(s)
Preferred Skills and Experience:
- RAPS Certification preferred
- Demonstrated experience in interpreting subjective and complex aspects of specific regulations
- Demonstrates in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes
- Demonstrated success in supporting product development and product support projects, including complex projects involving ambiguity and rapid change
- Demonstrated success in preparing, filing and/or completing (including negotiations) regulatory submissions
Skills
- Ability to analyze complex issues and to formulate sound approaches to resolving/addressing issues
- Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices
- Ability to handle multiple tasks and to prioritize and schedule work to meet business needs. Minimal supervision required.
Technical & Functional:
- Experience coordinating cross-functional inputs (i.e. R&D, Quality, Medical Affairs, Program Management, Marketing)
- Ability to compile and review documentation to support FDA submissions and EU IVDR documentation
- Understanding of regulatory submission processes and lifecycle management
Communication & Collaboration:
- Strong written and verbal communication skills
- Experience working with cross-functional, fast-moving teams
- Confidence in speaking up within cross-functional teams when regulatory risks are present
Process & Compliance:
- Familiarity with SOPs, regulatory procedures, and quality systems (e.g., ISO 13485)
- Ability to identify and support process improvements
Other:
- Strong organizational skills and ability to manage multiple submissions/projects simultaneously
- Adaptability to changing timelines and priorities
- Proficiency in Microsoft Office tools (Excel, Word, PowerPoint)
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.
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?
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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
LOCATION
Location
Sparks, Maryland
WORK SHIFT
At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."
Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.
Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
SALARY RANGE INFORMATION
$95,900.00 - $153,400.00 USD Annual
Becton, 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.
See All 78+ Regulatory Affairs Specialist Jobs
Jump back to the full list of openings and apply to any regulatory affairs specialist role that fits.
Find JobsRegulatory Affairs Specialist Job Market
A snapshot from current openings nationwide, updated as new roles post.
Who's Hiring
- Abbott8
- Insulet Corporation5
- BD4
- Evalve4
- Collabera3
Top Industries Hiring
- Biotechnology & Pharmaceuticals27
- Medical Devices23
- Healthcare & Medical Services12
- Distribution & Wholesale5
- Technology & Software5
What Employers Look For
The qualifications that appear most often in regulatory affairs specialist jobs.
- Bachelor's degree in life sciences, chemistry, engineering, or a related field
- Experience preparing and submitting regulatory filings such as 510(k), PMA, NDA, or BLA
- Knowledge of FDA regulations including 21 CFR parts relevant to the product type
- Proficiency with regulatory information management systems such as Veeva Vault or RIMS
- Regulatory Affairs Certification (RAC) from RAPS preferred for senior roles
- Strong technical writing skills for preparing regulatory summaries, briefing documents, and SOPs
Tips for Your Regulatory Affairs Specialist Job Search
Tailor your resume to submission types
Hiring managers scan for the specific submission formats you've worked on, whether 510(k), NDA, BLA, or CE marking. List each by name in your experience section so your resume clears automated filters built around those exact terms.
Highlight your regulatory database experience
Proficiency in tools like Veeva Vault, RIMS, or eCTD publishing software is a hard filter in many postings. Name the platforms you've used and the specific workflows you owned, not just the departments you supported.
Apply early to roles that fit
Migrate Mate lists 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.
Target postings by product stage
Regulatory roles differ sharply between pre-market, post-market, and life-cycle management work. Read each posting for the product pipeline stage it covers and match your examples to that phase in your cover letter.
Prepare a submission timeline walkthrough
Interviewers routinely ask you to walk through a submission from gap analysis to agency response. Practice narrating a real example end to end, including how you handled an information request or deficiency letter, before your first screening call.
Negotiate using agency-specific expertise
If you have direct FDA, EMA, or Health Canada interaction experience, name it explicitly when discussing compensation. Candidates who've attended advisory meetings or managed agency correspondence command a different conversation than those who haven't.
Regulatory Affairs Specialist Jobs: Frequently Asked Questions
Which companies are hiring the most regulatory affairs specialists?
The companies hiring the most regulatory affairs specialists right now include Abbott, Insulet Corporation, and BD, with the largest share of openings in California, Minnesota, and Massachusetts, based on current listings on Migrate Mate as of June 2026. Pharmaceutical manufacturers and medical device companies consistently account for the majority of open positions.
How many regulatory affairs specialist jobs are remote?
About 29% of regulatory affairs specialist openings are fully remote or hybrid as of June 2026, though on-site requirements vary by product type and company size. Post-market surveillance, labeling review, and regulatory intelligence roles tend to offer the most remote flexibility, while roles tied to lab operations or manufacturing sites typically require on-site presence.
How do you become a regulatory affairs specialist?
Most regulatory affairs specialists start with a bachelor's degree in a life science, pharmacy, or engineering discipline, then move into a quality, clinical, or scientific role at a regulated company to build product and process knowledge. Earning the RAC credential from RAPS accelerates hiring consideration, especially for roles requiring direct agency interaction. Specializing early in a single product category, such as combination products or IVDs, makes your profile more targeted and competitive.
Can you get a regulatory affairs specialist job with little experience?
Yes, entry-level regulatory affairs roles exist, particularly at companies hiring regulatory associates or coordinators to support document management, labeling, and submissions tracking. A background in quality assurance, clinical operations, or scientific writing transfers well into these roles. Internships at medical device startups or contract research organizations are among the most direct paths into the field without prior regulatory-specific titles.
What does the regulatory affairs specialist interview process look like?
The process typically begins with a recruiter screening focused on your regulatory background and product experience, followed by a technical interview with the hiring manager or a regulatory director who will ask you to walk through a specific submission or agency interaction you've managed. A final round often includes a panel with cross-functional partners from quality, clinical, or legal. Some companies add a written exercise, such as drafting a regulatory strategy memo or reviewing a gap analysis.
Where can I find and apply to regulatory affairs specialist jobs?
You can find and apply to regulatory affairs specialist jobs on Migrate Mate, which lists current openings from across the United States. Find roles that match your product experience, submission background, and preferred location, then apply directly to each listing without being redirected to a separate platform.
See All 78+ Regulatory Affairs Specialist Jobs
Jump back to the full list of openings and apply to any regulatory affairs specialist role that fits.
Find Jobs