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Intern Biomedical Regulatory Affairs Jobs (NOW HIRING)

CYNET SYSTEMS

Regulatory Affairs Specialist

Sunnyvale, CA · On-site

$55 - $60/hr

Minimum 8 years of regulatory affairs experience working in a medical device company (can be in ... Minimum B.S. or higher in Biomedical Engineering, Electrical Engineering, Mechanical Engineering ...

JobRx, Inc.

Director, Regulatory Affairs

Durham, NC · On-site

$130 - $160/hr

MS or advanced level degree in either chemistry, biological or biomedical related fields. * 10+ years demonstrated experience in drug regulatory affairs in the pharmaceutical or biotech industry.

AstraZeneca

Regulatory Affairs Director

Gaithersburg, MD · On-site

$162K - $213K/yr

Bachelor's degree in a science-related field such as life sciences, pharmacy, biomedical sciences, or a related discipline, with a minimum of 3 years' experience in regulatory affairs, regulatory ...

AstraZeneca

Regulatory Affairs Director

Gaithersburg, MD

$162K - $213K/yr

Bachelor's degree in a science-related field such aslife sciences, pharmacy, biomedical sciences, or a related discipline, with a minimum of3 years' experience in regulatory affairs, regulatory ...

Astrazeneca

Regulatory Affairs Director

Gaithersburg, MD

$162K - $213K/yr

Bachelor's degree in a science-related field such aslife sciences, pharmacy, biomedical sciences, or a related discipline, with a minimum of3 years' experience in regulatory affairs, regulatory ...

Pelthos Therapeutics

Director, Regulatory Affairs

Durham, NC · On-site

$135K - $179K/yr

MS or advanced level degree in either chemistry, biological or biomedical related fields. * 10+ years demonstrated experience in drug regulatory affairs in the pharmaceutical or biotech industry.

CONMED

Senior Manager, Regulatory Affairs

Englewood, CO · On-site

Bachelor's degree in science, biomedical engineering, engineering, regulatory affairs, or a related technical discipline. * Minimum 8 years of directly relevant Regulatory Affairs experience in the ...

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How much do intern biomedical regulatory affairs jobs pay per hour?

As of Aug 15, 2026, the average hourly pay for intern biomedical regulatory affairs in the United States is $16.69, according to ZipRecruiter salary data. Most workers in this role earn between $14.42 and $18.75 per hour, depending on experience, location, and employer.

What are some typical projects or tasks an intern in biomedical regulatory affairs might work on during their internship?

As an Intern in Biomedical Regulatory Affairs, you can expect to support the preparation and review of regulatory documents, assist with compiling data for submissions to regulatory agencies, and help monitor compliance with relevant laws and guidelines. Interns often participate in cross-functional meetings with teams such as Quality Assurance, Research & Development, and Clinical Affairs to understand the regulatory impact on product development. This hands-on experience provides valuable insight into the regulatory approval process and offers opportunities to develop skills in document management, research, and regulatory strategy.

What does an intern in biomedical regulatory affairs do?

An Intern in Biomedical Regulatory Affairs assists with ensuring that biomedical products comply with government regulations and industry standards. This role typically involves supporting the preparation and submission of regulatory documents, researching relevant regulations, and maintaining records for audits. Interns may also help coordinate communication between regulatory agencies and internal teams, learning about the lifecycle of medical devices, pharmaceuticals, or biotechnology products. This experience provides valuable insight into the regulatory environment of the biomedical industry.

What are the key skills and qualifications needed to thrive as an intern in biomedical regulatory affairs, and why are they important?

To thrive as an Intern in Biomedical Regulatory Affairs, you need a solid background in life sciences or biomedical engineering, attention to detail, and familiarity with regulatory guidelines such as FDA or EMA requirements. Experience with document management systems, regulatory submission platforms, and knowledge of standards like ISO 13485 is highly beneficial. Strong organizational skills, effective communication, and the ability to collaborate across teams help interns excel in this role. These skills ensure compliance, facilitate the approval process, and support bringing safe medical products to market efficiently.

What is the difference between Intern Biomedical Regulatory Affairs vs Intern Clinical Research Coordinator?

AspectIntern Biomedical Regulatory AffairsIntern Clinical Research Coordinator
Required CredentialsBasic life sciences background, knowledge of regulationsBackground in health sciences, familiarity with clinical protocols
Work EnvironmentRegulatory departments, compliance teamsClinical sites, hospitals, research centers
Employer & Industry UsagePharmaceutical, biotech, medical device companiesHospitals, research institutions, clinical trial sites
Common Search & Comparison IntentUnderstanding regulatory roles, career pathsClinical trial processes, patient coordination

Intern Biomedical Regulatory Affairs focuses on regulatory compliance, documentation, and ensuring products meet legal standards, often within pharmaceutical or biotech companies. Intern Clinical Research Coordinator involves managing clinical trials, patient interactions, and data collection at research sites. Both roles support clinical development but differ in focus and work environment.

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Intern Biomedical Regulatory Affairs jobs near you
Infographic showing various Intern Biomedical Regulatory Affairs job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 87% Full Time, 9% Part Time, and 3% Contract. Highlights an 90% Physical, 4% Hybrid, and 6% Remote job distribution, with an average salary of $34,721 per year, or $16.7 per hour.

Regulatory Affairs Specialist

ELITechGroup Inc.

Logan, UT • On-site

Full-time

Re-posted 19 days ago

Job description

Summary
This role is responsible for ensuring that all products comply with applicable global regulatory requirements throughout their lifecycle-from development and registration to post-market surveillance. The Regulatory Affairs Specialist helps ensure regulatory compliance for diagnostics products with FDA, Health Canada, EU, other regulatory bodies, ISO, and business objectives.
Essential Duties and Responsibilities
  • Implement company regulatory affairs procedures.
  • Prepare, compile, and submit regulatory documentation (e.g., 510(k), PMA, CE Technical Files) to global regulatory agencies and with guidance from Regulatory Affairs Manager manage regulatory submissions.
  • Interpret and apply FDA, EU MDR, ISO 13485, and other international regulations to ensure product compliance.
  • Collaborate with cross-functional teams (R&D, Quality, Clinical, Marketing) to support product development and regulatory strategy.
  • Review and approve product labeling, instructions for use (IFUs), and promotional materials for regulatory compliance.
  • Monitor and analyze changes in regulatory requirements and communicate updates to internal stakeholders.
  • Support internal and external audits, including FDA inspections and Notified Body assessments.
  • Maintain regulatory files and databases, ensuring accurate and up-to-date documentation.
  • Participate in post-market surveillance activities, including adverse event reporting and field actions.
  • Provide regulatory input during risk assessments and design control processes.

Qualifications
  • Bachelor's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field.
  • 2-5 years of experience in regulatory affairs, preferably in the medical device industry.
  • Strong understanding of FDA regulations (21 CFR Part 820), EU MDR, and ISO 13485.
  • Experience with regulatory submissions and product registrations in multiple global markets.
  • Excellent written and verbal communication skills.
  • Strong organizational and project management abilities.

Preferred Qualifications
  • RAC certification (Regulatory Affairs Certification).
  • Experience with electronic submission systems (e.g., eSTAR, EUDAMED).
  • Experience with MDSAP, ISO 14971 (risk management), and clinical evaluation reporting.

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