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Regulatory Affairs Analyst Jobs (NOW HIRING)

UDR

Governmental Affairs Analyst

Highlands Ranch, CO · On-site

$68.80K - $76.40K/yr

UDR, Inc. is now hiring a Governmental Affairs Analyst to join our team at our corporate office in ... N/A ESSENTIAL FUNCTIONS: 1. Develop advanced knowledge of regulatory frameworks through research ...

Accuray

Regulatory Affairs Intern

Madison, WI · On-site

The Regulatory Affairs Intern will support the Global Regulatory Affairs organization by driving ... Strong analytical and problem-solving skills. * Ability to work independently with guidance and ...

Accuray

Regulatory Affairs Intern

Madison, WI

The Regulatory Affairs Intern will support the Global Regulatory Affairs organization by driving ... Strong analytical and problem-solving skills. * Ability to work independently with guidance and ...

Pacer Group

Regulatory Affairs Specialist

Raleigh, NC · On-site

The ideal candidate will be curious, analytical and a self-starter, unafraid to ask questions or ... regulatory affairs, preferably with FDA class III devices. * Knowledge of Quality Management System ...

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How much do regulatory affairs analyst jobs pay per hour?

As of May 28, 2026, the average hourly pay for regulatory affairs analyst in the United States is $46.85, according to ZipRecruiter salary data. Most workers in this role earn between $37.74 and $53.85 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Regulatory Affairs Analyst, and why are they important?

To thrive as a Regulatory Affairs Analyst, you need a solid background in regulatory guidelines, compliance, and scientific or legal knowledge, often backed by a degree in life sciences, pharmacy, or a related field. Familiarity with regulatory databases, document management systems, and certifications like RAC (Regulatory Affairs Certification) are highly valued. Strong analytical thinking, attention to detail, and effective communication skills help professionals excel in interpreting regulations and liaising with multiple stakeholders. These skills ensure that products meet legal standards and market requirements, minimizing risk and facilitating smooth regulatory approvals.

How does a Regulatory Affairs Analyst typically collaborate with cross-functional teams within an organization?

Regulatory Affairs Analysts work closely with departments such as research and development, quality assurance, clinical operations, and manufacturing to ensure that products comply with relevant regulations. They often facilitate communication between these teams to gather necessary documentation, interpret guidelines, and address compliance issues. This collaboration is essential for preparing regulatory submissions, responding to agency questions, and implementing regulatory changes efficiently. Strong interpersonal and organizational skills are vital for successful cross-functional teamwork in this role.

What does a Regulatory Affairs Analyst do?

A Regulatory Affairs Analyst is responsible for ensuring that a company complies with all regulations and laws relevant to its business. They prepare and submit documentation to regulatory agencies, monitor changes in regulations, and advise on compliance strategies. Their work is particularly important in industries like pharmaceuticals, biotechnology, and medical devices, where regulatory compliance is critical. Regulatory Affairs Analysts also coordinate with other departments to ensure that products meet legal standards and are approved for market.

What is the difference between Regulatory Affairs Analyst vs Quality Assurance Analyst?

AspectRegulatory Affairs AnalystQuality Assurance Analyst
Required CredentialsBachelor's in life sciences, certifications like RAC often preferredBachelor's in related fields, certifications like CQE may be advantageous
Work EnvironmentRegulatory agencies, pharmaceutical, biotech companiesManufacturing, pharmaceutical, healthcare companies
Employer & Industry UsageFocuses on compliance with regulations and submissionsFocuses on product quality, testing, and process improvements

While both roles require knowledge of industry standards and compliance, Regulatory Affairs Analysts primarily handle regulatory submissions and compliance documentation, whereas Quality Assurance Analysts focus on product quality testing and process improvements. Both roles are essential in regulated industries like pharmaceuticals and biotech, but they serve different functions within the product lifecycle.

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Regulatory Affairs Analyst jobs near you
Infographic showing various Regulatory Affairs Analyst job openings in the United States as of May 2026, with employment types broken down into 56% Full Time, 31% Part Time, and 13% Contract. Highlights an 76% Physical, 3% Hybrid, and 21% Remote job distribution, with an average salary of $97,449 per year, or $46.9 per hour.

Sr. Regulatory Affairs SME - Medical Devices

Tunnell Government Services

Bethesda, MD • On-site

Full-time

Posted 14 days ago

Job description

Tunnell Government Services, Inc., is comprised of the industry's leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals. If you are interested in joining an employee-owned company that develops and implements innovative, integrated and differentiated solutions, please click on the links below to find the job that is right for you and contact us.
Sr. Regulatory Affairs SME - Medical Devices
Background: A Regulatory Affairs Analyst/subject matter expert is needed to provide contracted staffing support to the Biomedical Advanced Research and Development Authority (BARDA), within the U.S. Department of Health and Human Services in Washington, DC. The mission of BARDA is to develop and procure medical countermeasures that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases (EID). Specifically, BARDA supports the advanced development and procurement of drugs, vaccines and other products that are considered priorities for national health security. For more information on BARDA please visit their website at: https://aspr.hhs.gov/AboutASPR/ProgramOffices/BARDA/Pages/default.aspx and specifically the Division of Regulatory and Quality Affairs: https://medicalcountermeasures.gov/barda/rqa
Duties of the position: This position will serve as regulatory affairs subject matter expert for multiple BARDA programs and projects involving development and manufacturing of in vitro diagnostic and device medical countermeasures specific to influenza, emerging infectious disease, CBRN threats (e.g. anthrax, filovirus, burn/blast trauma assessment, etc.), sepsis, and digital health technologies. These are products which are regulated by FDA's Center for Devices and Radiological Health (CDRH) and/or combination products crossing multiple centers. This technical advisory support covers the entire range from the inception of requirements to placing FDA cleared or approved products into the Strategic National Stockpile. Specific duties may include but are not limited to:
  • Provide regulatory affairs expertise and guidance for assigned programs and projects
  • Monitor 21CFR compliance on assigned programs and projects
  • Support BARDA in the review of contract-related documents, including regulatory strategy, development plans, study reports, study protocols and progress reports
  • Review and provide feedback on contractor FDA submissions, which may include IDEs, Pre-submissions (Q-subs), Premarket Submissions (510(k)), Premarket Applications (PMA), CLIA waivers etc.
  • Assist in preparation for contractor submission meetings with FDA, as assigned.
  • Attend contractor submission meetings with FDA and interpret FDA feedback as appropriate
  • Monitor BARDA supported contractors' project timelines for key regulatory and quality performance measures, and provide recommendations to overcome challenges and reduce program risk
  • Participate in site visits/audits to review and monitor vendor progress toward completion of contract milestones
  • Assist Project Team and BARDA supported contractors to develop and manage strategy, protocols and FDA applications for Emergency Use Authorizations
  • Participate or act as regulatory representative on various cross-functional teams, as assigned
  • Maintain current knowledge of the US competitive landscape, regulatory environment, regulations and guidance
  • Provide regulatory opinions on specific issues
  • Support contract initiation/negotiation efforts by providing regulatory and quality assessments of white papers and proposals to BARDA
  • Provide regulatory expertise on draft Statements of Work (SOW) for upcoming Requests for Proposals (RFP) and support technical and cost evaluation for white papers/proposals
  • Draft meeting minutes, trip reports, and technical assessments and recommendations (including regulatory opinions) on the regulatory aspects of BARDA-contractor interactions

Education:
  • M.S. or higher in life sciences or related field is highly preferred

Desired Experience:
  • Minimum 15 years of device development; Government or industry experience in regulatory and/or quality affairs for diagnostic devices, particularly seeking expertise with imaging devices, software as a medical device, in vitro diagnostic devices, wearable technologies, digital health, and home use diagnostics.
  • Experienced in addressing FDA/CDRH hurdles (especially during late stage product development)
  • Experience in identifying and resolving quality, regulatory, clinical or process development problems for medical devices
  • Excellent people and communication skills, with a team-oriented leadership style

Must be US Citizen or Full Green Card holder.
Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.

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