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Fda Regulatory Affairs Jobs (NOW HIRING)

Regulatory Affairs Specialist (FDA, DEA )

Irvine, CA · On-site

$60K - $76K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Job Summary The Regulatory Affairs Specialist (FDA, DEA) will ensure BaRupOn's pharmacy, manufacturing, and healthcare operations meet all applicable regulatory requirements. This position is ...

Regulatory Affairs Specialist (FDA, DEA )

Irvine, CA · On-site

$60K - $76K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Job Summary The Regulatory Affairs Specialist (FDA, DEA) will ensure BaRupOn's pharmacy, manufacturing, and healthcare operations meet all applicable regulatory requirements. This position is ...

The Regulatory Affairs Specialist will be responsible for regulatory documentation, compliance ... Knowledge of FDA regulations and guidelines * Knowledge of cGMP * Comfortable working directly for ...

Director, Regulatory Affairs Department: Pharmaceutical Development About Pelthos: Pelthos ... Serves as the primary contact for all interactions with regulatory agencies such as the FDA.

$160 - $200/hr

  • Medical

  • Retirement

  • PTO

Principal Regulatory Affairs Specialist Location: Remote (U.S. only, excluding Alaska and Hawaii ... Run FDA Pre-Submissions - Draft Pre-Sub packages, prepare client teams for meetings, lead the FDA ...

New

Prepare, review, and submit regulatory documents to ensure compliance with FDA and other regulatory ... Previous experience in a regulatory affairs role within the pharmaceutical industry is preferred.

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Fda Regulatory Affairs information

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$145

How much do fda regulatory affairs jobs pay per hour?

As of Aug 17, 2026, the average hourly pay for fda regulatory affairs in the United States is $34.60, according to ZipRecruiter salary data. Most workers in this role earn between $22.36 and $26.20 per hour, depending on experience, location, and employer.

What is FDA Regulatory Affairs?

FDA Regulatory Affairs refers to the field focused on ensuring that companies comply with regulations set by the U.S. Food and Drug Administration (FDA) for products such as pharmaceuticals, medical devices, food, and cosmetics. Professionals working in FDA Regulatory Affairs help manage submissions, approvals, and ongoing compliance throughout the product lifecycle. Their work is essential for bringing safe and effective products to market while avoiding regulatory issues. They also stay updated on changing regulations and communicate requirements to internal teams.

What are the key skills and qualifications needed to thrive as an FDA Regulatory Affairs professional, and why are they important?

To thrive as an FDA Regulatory Affairs professional, you need a strong background in life sciences, regulatory guidelines, and compliance, often supported by a relevant degree and regulatory affairs certification. Familiarity with FDA submission systems (such as eCTD), regulatory databases, and document management tools is essential. Excellent attention to detail, problem-solving abilities, and effective communication skills help in interpreting regulations and collaborating with cross-functional teams. These competencies ensure accurate submissions, successful product approvals, and maintain company compliance with FDA regulations.

What are some common challenges faced by professionals in FDA Regulatory Affairs, and how can applicants prepare to address them?

Professionals in FDA Regulatory Affairs often encounter challenges such as keeping up with frequently changing regulations, managing tight submission deadlines, and ensuring cross-functional teams remain compliant. To prepare, applicants should develop strong organizational and communication skills, stay current with FDA guidance documents, and gain experience working with multidisciplinary teams. Being proactive about learning regulatory updates and demonstrating attention to detail will help you succeed and add value to your organization.
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What cities are hiring for Fda Regulatory Affairs jobs?

Cities with the most Fda Regulatory Affairs job openings:

What states have the most Fda Regulatory Affairs jobs?

States with the most job openings for Fda Regulatory Affairs jobs include:

Infographic showing various Fda 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 $71,960 per year, or $34.6 per hour.

Senior FDA Regulatory Affairs Specialist - Medical Devices

Elucent Medical, Inc.

Eden Prairie, MN • On-site

$90 - $120/hr

Other

Posted 11 days ago


Job description

Elucent Medical, Inc. is hiring a Principal Regulatory Affairs Specialist in Eden Prairie, MN. This role requires advanced knowledge of U.S. FDA regulations to oversee regulatory strategies, submissions, and compliance for medical devices. The position emphasizes hands-on execution and collaboration with cross-functional teams to ensure regulatory adherence throughout product lifecycles.

The ideal candidate will have a strong background in preparing FDA submissions and a minimum of 7 years of related experience, showcasing their ability to navigate complex regulatory landscapes effectively.

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