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Biomedical Regulatory Affairs Jobs (NOW HIRING)

CorDx

Regulatory Affairs Manager - IVD

San Diego, CA · On-site

$120 - $170/hr

The Regulatory Affairs Manager will lead regulatory strategy and submissions for diagnostic ... Bachelor's degree or higher in Biology, Chemistry, Biomedical Engineering, Clinical Laboratory ...

CorDx

Regulatory Affairs Manager - IVD

San Diego, CA · On-site

The Regulatory Affairs Manager will lead regulatory strategy and submissions for diagnostic ... Bachelor's degree or higher in Biology, Chemistry, Biomedical Engineering, Clinical Laboratory ...

CorDx

Regulatory Affairs Manager - IVD

San Diego, CA · On-site

The Regulatory Affairs Manager will lead regulatory strategy and submissions for diagnostic ... Bachelor's degree or higher in Biology, Chemistry, Biomedical Engineering, Clinical Laboratory ...

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 ...

CorDx

Regulatory Affairs Manager - IVD

San Diego, CA · On-site

The Regulatory Affairs Manager will lead regulatory strategy and submissions for diagnostic ... Bachelor's degree or higher in Biology, Chemistry, Biomedical Engineering, Clinical Laboratory ...

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How much do biomedical regulatory affairs jobs pay per hour?

As of Sep 1, 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.

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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, 88% Full Time, 9% Part Time, and 2% Contract. Highlights an 90% Physical, 3% Hybrid, and 7% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.

Regulatory & Clinical Affairs Manager

Cox-Little & Company

Princeton, NJ • On-site

Other

Posted 18 days ago

Job description

Role: Regulatory & Clinical Affairs Manager

Locations : Princeton, NJ (Onsite)

(Full Time /Permanent)

Note* FULLTIME Role and This role is on-site at Princeton, NJ

The Role

The Regulatory & Clinical Affairs Manager will play a key role in supporting the Company s regulatory and clinical initiatives across product development, regulatory submissions, and hospital collaborations.

This position is intended for a motivated professional seeking to grow into increasing levels of responsibility within a dynamic medical device environment. The successful candidate will be expected to independently manage assigned projects and develop well-reasoned regulatory recommendations, while working closely with cross-functional teams on overall regulatory and clinical strategy.

This role offers significant opportunities for professional growth, increased ownership, and direct exposure to executive-level strategic planning, regulatory agency interactions, and clinical partnerships.

The position combines regulatory affairs, clinical affairs, and hospital collaboration activities, supporting innovative AI-enabled medical imaging, surgical planning, surgical navigation, and digital health technologies.

Primary Responsibilities:

  • Preparation and execution of regulatory submissions, including FDA 510(k) submissions, software modifications, and international registrations as applicable.
  • Assess regulatory impact of software, AI/ML, cybersecurity, and product changes.
  • Develop regulatory strategies and recommendations for new products and software upgrades.
  • Support interactions with FDA, notified bodies, regulatory consultants, and international regulatory agencies.
  • Monitor evolving regulatory requirements and communicate potential impacts to the organization.
  • Support regulatory assessments related to design changes, risk management, verification, validation, and clinical evidence.

Qualifications:

  • Bachelor s degree in engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, or related field.
  • 5-12 years of experience in medical device regulatory affairs.
  • Hands-on experience on FDA, CE, EU MDR submissions - candidates themselves shall still be active in preparing the submissions, rather than serving only in a managerial or oversight capacity
  • Experience with Software as a Medical Device (SaMD)/SiMD, AI/ML-enabled medical devices, medical imaging, surgical navigation, robotics, or digital health products.
  • Experience preparing and/or leading FDA 510(k) submissions.
  • Experience supporting clinical studies, IRB submissions, or hospital-based research collaborations
  • Familiarity with medical device quality systems and standards, including ISO 13485, ISO 14971, and IEC 62304.
  • Experience with EU MDR and Technical Documentation submissions.
  • Clinical affairs experience is a plnice to have

Apply