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Regulatory Affairs Manager Biotech Jobs (NOW HIRING)

Lesaffr

Regulatory Affairs Manager

Chicago, IL · On-site

$120 - $180/hr

Serving leading nutraceutical and pharmaceutical brands, Gnosis harnesses the latest biotechnology ... As our Manager, Regulatory Affairs, you'll be the strategic engine behind our Americas growth ...

Daikin

Regulatory Affairs Manager

Santa Clara, CA · On-site

$120K - $145K/yr

The Regulatory Affairs Manager is responsible for monitoring, interpreting, and influencing regulatory and standards requirements that impact HVAC products and systems within the West Coast region ...

Lesaffr

Regulatory Affairs Manager

Manhattan, NY · On-site

$120 - $180/hr

Serving leading nutraceutical and pharmaceutical brands, Gnosis harnesses the latest biotechnology ... As our Manager, Regulatory Affairs, you'll be the strategic engine behind our Americas growth ...

Daikin

Regulatory Affairs Manager

Santa Clara, CA · On-site

$120K - $145K/yr

The Regulatory Affairs Manager is responsible for monitoring, interpreting, and influencing regulatory and standards requirements that impact HVAC products and systems within the West Coast region ...

Daikin

Regulatory Affairs Manager

Santa Clara, CA · On-site

$120K - $145K/yr

The Regulatory Affairs Manager is responsible for monitoring, interpreting, and influencing regulatory and standards requirements that impact HVAC products and systems within the West Coast region ...

Lesaffre Group

Regulatory Affairs Manager

Serving leading nutraceutical and pharmaceutical brands, Gnosis harnesses the latest biotechnology ... As our Manager, Regulatory Affairs, you'll be the strategic engine behind our Americas growth ...

Harbor Health

Regulatory Affairs Manager

Austin, TX · On-site +1

Description Harbor Health POSITION OVERVIEW The Regulatory Affairs Manager plays a pivotal role in supporting Harbor Health's health plan business by ensuring regulatory compliance with the Texas ...

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How much do regulatory affairs manager biotech jobs pay per hour?

As of Sep 6, 2026, the average hourly pay for regulatory affairs manager biotech in the United States is $56.97, according to ZipRecruiter salary data. Most workers in this role earn between $42.07 and $66.59 per hour, depending on experience, location, and employer.

What does a regulatory affairs manager do in the biotech industry?

A Regulatory Affairs Manager in the biotech industry oversees the process of ensuring that biotechnology products comply with all relevant regulations and standards. They work closely with regulatory agencies like the FDA or EMA to obtain approvals for new drugs, devices, or therapies. This role involves preparing and submitting documentation, staying updated on changing regulations, and guiding cross-functional teams to ensure products meet safety and efficacy requirements. Their work is essential for bringing new biotech innovations to market in a compliant manner.

How does a regulatory affairs manager in biotech typically collaborate with cross-functional teams during product development?

A Regulatory Affairs Manager in biotech plays a crucial role in bridging the gap between regulatory agencies and internal teams such as research & development, clinical, quality assurance, and manufacturing. They guide these teams on regulatory requirements, review documentation for compliance, and coordinate regulatory submissions. Frequent meetings and clear communication are essential, as the manager ensures all stakeholders understand timelines, data requirements, and any changes in regulations, ultimately supporting a smoother pathway to product approval.

What are the key skills and qualifications needed to thrive as a regulatory affairs manager in the biotech industry, and why are they important?

To thrive as a Regulatory Affairs Manager in biotech, you need in-depth knowledge of regulatory guidelines, scientific principles, and compliance processes, typically supported by a degree in life sciences or a related field. Familiarity with submission management systems, regulatory databases, and certifications such as RAC (Regulatory Affairs Certification) are highly valued. Excellent communication, problem-solving, and project management skills distinguish top professionals in this role. These abilities ensure that biotech products meet all regulatory requirements efficiently, minimizing risk and accelerating product approval timelines.

What is the difference between Regulatory Affairs Manager Biotech vs Regulatory Affairs Specialist Biotech?

AspectRegulatory Affairs Manager BiotechRegulatory Affairs Specialist Biotech
CredentialsBachelor's or Master’s in Life Sciences, often with certifications like RACBachelor's or Master’s in Life Sciences, often with certifications like RAC
Work EnvironmentLeads teams, manages projects, interacts with regulatory agenciesSupports regulatory submissions, prepares documentation, assists managers
Employer & Industry UsageBiotech companies, pharmaceutical firms, regulatory agenciesBiotech companies, contract research organizations, regulatory consulting firms

The Regulatory Affairs Manager Biotech typically oversees regulatory strategies, manages teams, and interacts with authorities, requiring more experience and leadership skills. In contrast, the Regulatory Affairs Specialist Biotech focuses on supporting documentation and submission processes, often serving as part of a team. Both roles require similar credentials but differ in scope and responsibility.

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Regulatory Affairs Manager Biotech jobs near you
Infographic showing various Regulatory Affairs Manager Biotech job openings in the United States as of August 2026, with employment types broken down into 87% Full Time, 12% Part Time, and 1% Contract. Highlights an 87% Physical, 2% Hybrid, and 11% Remote job distribution, with an average salary of $118,493 per year, or $57 per hour.

Senior Regulatory Affairs Manager (Onsite)

CorDx

Atlanta, GA • On-site

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 5 days ago

Job description

Who is CorDx？  
 

CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.  
 

Job Type: Full time  
Job Title: Senior Regulatory Affairs Manager
Location: Onsite - Atlanta, or San Diego

Position Summary:

The Senior Regulatory Affairs Manager will play a crucial role in leading and managing the regulatory submissions for CorDx medical device products, including 510(k) and submissions. This individual will ensure compliance with all applicable regulations in the preparation of the submissions to FDA, provide regulatory guidance to cross-functional teams, and contribute to the successful approval and launch of innovative medical devices.

Key Responsibilities:

  • Prepare, review, and submit regulatory documents to FDA.
  • Manage and oversee the regulatory submission process, ensuring timely and successful clearances/approvals.
  • Ensure that all products comply with applicable regulatory requirements, including FDA regulations and ISO standards.
  • Provide regulatory guidance to R&D team during product development life cycle. 
  • Stay updated on changes in regulatory requirements and communicate potential impacts to the organization.
  • Conduct regulatory assessments for product changes and provide recommendations for appropriate regulatory pathways.
  • Collaborate with internal stakeholders and external partners to ensure alignment on regulatory strategies and project timelines.
  • Represent the company in meetings with regulatory agencies and external partners as needed.
  • Ensure proper documentation and maintenance of regulatory submissions and correspondence with regulatory agencies.

Requirements

  • Master’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related field; advanced degree preferred.
  • Minimum of 7-10 years of experience in regulatory affairs within the medical device industry.
  • Proven track record of leading and successfully obtaining 510(k) and clearances/approvals.
  • Experience in interacting with FDA and other regulatory agencies.

Skills & Competencies:

  • In-depth knowledge of FDA regulations, 21 CFR Part 820, ISO 13485, and other applicable medical device regulations.
  • Strong leadership and project management skills, with the ability to manage multiple projects and priorities.
  • Excellent communication, negotiation, and problem-solving skills.
  • Ability to work collaboratively in a cross-functional team environment.
  • Detail-oriented with strong organizational skills.

Benefits

  • Highly competitive compensation package.
  • Comprehensive medical, dental, and vision insurance.
  • 401(k) plan with generous company contributions.
  • Flexible paid time off (PTO) policy.
  • Additional substantial benefits.

Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.