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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 ...

Actalent

Regulatory Affairs Specialist

Baldwin, NY

$75K - $90K/yr

Bachelor's degree in Regulatory Affairs, Biomedical Sciences, Engineering, Life Sciences, or a related field. * 3-5 years of Regulatory Affairs experience within the medical device 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 ...

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.

New

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 · On-site

$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 · On-site

$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.

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 ...

New

Kodak

Regulatory Affairs Lead

Rochester, NY

$125K - $130K/yr

Bachelor's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field required. 6-8 years of Regulatory Affairs experience within the medical device industry.

Kodak

Regulatory Affairs Lead

Rochester, NY · On-site

$125K - $130K/yr

Qualifications (Education, Experiences and Skills): • Bachelor's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field required. • 6-8 years of Regulatory ...

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Biomedical Regulatory Affairs information

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How much do biomedical regulatory affairs jobs pay per hour?

As of Aug 7, 2026, the average hourly pay for biomedical regulatory affairs in the United States is $39.57, according to ZipRecruiter salary data. Most workers in this role earn between $31.73 and $46.88 per hour, depending on experience, location, and employer.

What is a biomedical regulatory affairs?

A Biomedical Regulatory Affairs job involves ensuring that medical products, such as drugs, medical devices, and biologics, comply with government regulations and industry standards. Professionals in this field work closely with regulatory agencies like the FDA, EMA, or other global authorities to secure approvals, maintain compliance, and oversee product life cycles. They prepare and submit regulatory documents, monitor changes in regulations, and advise companies on compliance strategies. Their role is critical in bringing safe and effective healthcare products to market while meeting legal and ethical requirements.

What does a biomedical regulatory affairs professional do?

A Biomedical Regulatory Affairs professional is responsible for preparing and submitting regulatory documents for product approvals, reviewing scientific data for compliance, and liaising with regulatory agencies such as the FDA or EMA. You’ll frequently collaborate with research and development, clinical, and quality assurance teams to gather information and resolve compliance issues. Additionally, staying updated on changing regulations and proactively advising internal teams is a key part of the role. These responsibilities ensure that biomedical products meet safety, efficacy, and quality standards while progressing smoothly through the regulatory process.

What are the key skills and qualifications needed to thrive in biomedical regulatory affairs?

To excel in Biomedical Regulatory Affairs, you need a strong background in biomedical sciences or engineering, familiarity with regulatory guidelines (like FDA, EMA), and a keen attention to detail. Experience with electronic submission systems (such as eCTD), knowledge of clinical trial documentation, and certifications like RAC (Regulatory Affairs Certification) are highly valuable. Stellar communication, organizational skills, and the ability to work cross-functionally help professionals effectively navigate regulatory pathways and build consensus. These competencies are essential for ensuring compliance, facilitating timely product approvals, and supporting overall business goals in a highly regulated industry.

More about Biomedical Regulatory Affairs jobs
What cities are hiring for Biomedical Regulatory Affairs jobs? Cities with the most Biomedical Regulatory Affairs job openings:
What are the most commonly searched types of Biomedical Regulatory Affairs jobs? The most popular types of Biomedical Regulatory Affairs jobs are:
What states have the most Biomedical Regulatory Affairs jobs? States with the most job openings for Biomedical Regulatory Affairs jobs include:
What job categories do people searching Biomedical Regulatory Affairs jobs look for? The top searched job categories for Biomedical Regulatory Affairs jobs are:
Biomedical Regulatory Affairs jobs near you
Infographic showing various Biomedical Regulatory Affairs job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 86% Full Time, 9% Part Time, and 4% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.

Regulatory Affairs Associate

Stark Pharma Solutions Inc

Piscataway, NJ • On-site

Contractor

Re-posted 3 days ago

Job description

Hi,

My name is Karthik Mutyala, and I am a Recruitment Manager with Stark Pharma Solutions, specializing in opportunities across the Pharmaceutical, Biotechnology, Medical Device, and Life Sciences industries.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.

Role: Regulatory Affairs Associate

Location: United States

Duration: Long Term contract

Position Summary

We are seeking a detail-oriented Regulatory Affairs Associate to support regulatory activities for medical devices, pharmaceuticals, biotechnology products, or combination products. The successful candidate will assist in preparing regulatory submissions, maintaining regulatory documentation, monitoring compliance requirements, and supporting product registrations to ensure adherence to FDA and global regulatory standards.

Key Responsibilities

  • Prepare, compile, review, and submit regulatory documentation to support product approvals and registrations.
  • Assist in the preparation of FDA submissions, including 510(k), PMA, IND, NDA, ANDA, or other regulatory filings as applicable.
  • Support regulatory strategy development for new products, product modifications, and market expansions.
  • Maintain regulatory files, product registrations, licenses, and submission records.
  • Review product labeling, promotional materials, and technical documentation for regulatory compliance.
  • Monitor changes in U.S. and international regulations and communicate regulatory impacts to internal stakeholders.
  • Collaborate with Quality Assurance, R&D, Clinical, Manufacturing, and Marketing teams to support regulatory initiatives.
  • Assist with regulatory agency correspondence, inspections, audits, and information requests.
  • Support change control assessments and evaluate regulatory impact of product or process changes.
  • Participate in cross-functional project teams to ensure timely regulatory deliverables.

Required Qualifications

  • Bachelor's degree in Regulatory Affairs, Life Sciences, Pharmacy, Biology, Chemistry, Biomedical Engineering, or a related scientific discipline.
  • 1–3 years of Regulatory Affairs experience within the pharmaceutical, biotechnology, medical device, or healthcare industry.
  • Working knowledge of FDA regulations, guidance documents, and regulatory submission processes.
  • Strong technical writing, documentation, and organizational skills.
  • Ability to manage multiple projects and deadlines in a fast-paced environment.
  • Excellent verbal and written communication skills.