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Fda Regulatory Affairs Associate Jobs (NOW HIRING)

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Regulatory Affairs Associate

Norman, OK · Remote

S. Job Purpose The Regulatory Affairs Associate/Specialist is primarily responsible for preparing ... Familiarity with FDA, IVDD, IVDR, ISO 13485, GMP and other major international regulatory ...

Stark Pharma Solutions Inc

IL · On-site

I am working on Regulatory Affairs Associate I position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed is as follows. Job ...

Collaborative LLC

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Entry-Level Regulatory Affairs Associate

South Portland, ME · On-site

$20 - $23/hr

Entry-Level Regulatory Affairs Associate Location: South Portland, ME Pay: $20-$23 per hour Schedule: Monday-Friday, 7:00 AM-4:30 PM We are seeking an Entry-Level Regulatory Affairs Associate to ...

ITW Car Care

Regulatory Affairs Associate

Lakeland, FL · Hybrid

Position Summary The Regulatory Affairs Associate supports the organization's product stewardship and regulatory compliance programs by ensuring products meet applicable environmental, health, safety ...

Abbott

Regulatory Affairs Associate

South Portland, ME · On-site

$19 - $21/hr

Regulatory Affairs Associate Location: South Portland, ME Duration: 12 Months Shifts: 8AM TO 4:30PM 100% Onsite Main Responsibilities: * As the Experienced para-professional in the Regulatory Affairs ...

CorDx

Regulatory Affairs Manager - IVD

San Diego, CA · On-site

The Regulatory Affairs Manager will lead regulatory strategy and submissions for diagnostic ... FDA Submissions * Lead preparation, review, and submission of FDA regulatory applications ...

CorDx

Regulatory Affairs Manager - IVD

San Diego, CA · On-site

The Regulatory Affairs Manager will lead regulatory strategy and submissions for diagnostic ... FDA Submissions * Lead preparation, review, and submission of FDA regulatory applications ...

CorDx

Regulatory Affairs Manager - IVD

San Diego, CA · On-site

The Regulatory Affairs Manager will lead regulatory strategy and submissions for diagnostic ... FDA Submissions * Lead preparation, review, and submission of FDA regulatory applications ...

CorDx

Regulatory Affairs Manager - IVD

San Diego, CA · On-site

The Regulatory Affairs Manager will lead regulatory strategy and submissions for diagnostic ... FDA Submissions * Lead preparation, review, and submission of FDA regulatory applications ...

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Fda Regulatory Affairs Associate information

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How much do fda regulatory affairs associate jobs pay per hour?

As of Sep 13, 2026, the average hourly pay for fda regulatory affairs associate 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 an FDA Regulatory Affairs Associate?

FDA Regulatory Affairs Associates are professionals who ensure that companies comply with all regulations and laws set forth by the U.S. Food and Drug Administration (FDA) when developing, manufacturing, and marketing products such as pharmaceuticals, medical devices, and food items. They prepare and submit regulatory documents, communicate with regulatory agencies, and monitor changes in legislation to help guide their organization's compliance strategies. Their role is crucial to securing product approvals and maintaining ongoing compliance throughout the product lifecycle.

What are the key skills and qualifications needed to thrive as an FDA Regulatory Affairs Associate?

To thrive as an FDA Regulatory Affairs Associate, you need a solid understanding of regulatory guidelines, scientific principles, and a bachelor's degree in a life science or related field. Familiarity with regulatory submission systems (e.g., eCTD), document management tools, and knowledge of FDA regulations are typically required, and certification such as RAC can be advantageous. Strong attention to detail, problem-solving abilities, and clear written and verbal communication help professionals excel in this role. These skills are vital for ensuring compliance, minimizing approval delays, and facilitating successful product registrations with the FDA.

What are some common challenges faced by an FDA Regulatory Affairs Associate when preparing submissions?

FDA Regulatory Affairs Associates often encounter challenges such as interpreting evolving regulatory guidelines, coordinating data collection from cross-functional teams, and ensuring all submission documents are accurate and compliant with FDA requirements. Keeping up with frequent regulatory updates and communicating complex requirements to scientists and management can also be demanding. However, these challenges provide valuable experience in problem-solving and project management, which are essential for career advancement in regulatory affairs.

What is the difference between Fda Regulatory Affairs Associate vs Fda Regulatory Affairs Specialist?

AspectFda Regulatory Affairs AssociateFda Regulatory Affairs Specialist
CredentialsBachelor's degree in life sciences or related field; certifications like RAC are commonSimilar credentials; often holds RAC or advanced certifications
Work EnvironmentEntry-level role in pharmaceutical or biotech companies, regulatory agencies, or consulting firmsMid-level role with more independent responsibilities in similar settings
Employer & IndustryPharmaceutical, biotech, medical device companies, regulatory agenciesSame industries, with increased focus on compliance and submissions

The main difference is experience level and responsibility. Fda Regulatory Affairs Associates typically handle supporting tasks and document preparation, while Fda Regulatory Affairs Specialists take on more complex regulatory strategies and submissions. Both roles require similar credentials and work in comparable environments, but specialists usually have more independence and expertise.

What are popular job titles related to Fda Regulatory Affairs Associate jobs?

For Fda Regulatory Affairs Associate jobs, the most frequently searched job titles are:

Infographic showing various Fda Regulatory Affairs Associate job openings in the United States as of June 2026, with employment types broken down into 69% Full Time, and 31% Part Time. Highlights an 94% Physical, 1% Hybrid, and 5% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.

Regulatory Affairs Associate II

Seattle, WA • On-site

INBIOS INTERNATIONAL INC
Biotechnology Research and Development • 51 - 200 employees
Learn more about INBIOS INTERNATIONAL INCexternal

$91K - $125K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 21 days ago

Key responsibilities

  • Support the development, registration, and lifecycle management of in vitro diagnostic (IVD) products.

  • Write and review protocols for analytical studies and assist in preparing regulatory submissions such as EUAs, 510(k)s, and pre-submissions.

  • Support international registrations, create and maintain technical files, prepare product dossiers, and ensure regulatory compliance of labeling and marketing materials.

Job description

Description: About the Opportunity

We are seeking a highly motivated and detail-oriented Regulatory Affairs professional to join our team. This position supports the development, registration, commercialization, and lifecycle management of innovative in vitro diagnostic (IVD) products designed to address emerging infectious diseases and biothreats.


The ideal candidate has a strong understanding of U.S. and international regulatory requirements for diagnostic products and is experienced in preparing regulatory submissions and supporting cross-functional product development teams. You are proactive, organized, and capable of managing multiple priorities while working collaboratively with scientific, quality, manufacturing, and commercial teams. If you enjoy solving complex regulatory challenges and helping bring impactful diagnostic solutions to market, we encourage you to apply.


This is a regular full-time position that will be supported by project-based funding. The anticipated duration of the funded project is approximately one (1) year. While InBios hopes to retain successful team members beyond the initial project period, continued employment will depend on business needs, project requirements, and the availability of future funding through contract renewals, expanded programs, or new initiatives.


About Us

InBios International Inc. has been advancing diagnostic solutions since 1996, specializing in the design, development, and manufacturing of assays for emerging infectious diseases and biothreats. Our work supports global health initiatives and government-funded programs, with a strong focus on innovation, quality, and compliance.

Based in Seattle, WA, we offer a collaborative, mission-driven culture where employees contribute to meaningful work that impacts lives worldwide.


About the Position
  • Position Title: Regulatory Affairs Associate II
  • Location: Seattle, WA
  • Employment Type: Full-time, exempt | On-site (Hybrid option may be available after employee is established in the position.)
  • Position Pay Range: $91,500 - $125,000 annually (based on knowledge, skills, and experience)


What You’ll Do
  • Represent and/or lead Regulatory Affairs in project teams throughout product life cycle.
  • Write/review protocols for analytical studies in support of regulatory submissions.
  • Assist in the preparation and submission of EUAs, pre-submissions, 510(k)s for class II products.
  • Support international registrations, create and maintain technical files, and prepare product dossiers.
  • Prepare and maintain Design History Files.
  • Lead Risk Management effort.
  • Prepare and review labeling and marketing materials to ensure regulatory compliance.
  • Help set the regulatory strategy for new product development.
  • Keep abreast with the latest regulatory requirements and trends.
  • Communicate with the FDA and other regulatory bodies concerning product submissions.


What We’re Looking For
  • Bachelor's or Master's degree in Life Sciences, Bioengineering, Regulatory Affairs, or a related discipline.
  • Minimum of 5 years of regulatory affairs experience within an FDA-regulated IVD manufacturing environment, or a Ph.D. with at least 2 years of applicable industry experience.
  • Certification in regulatory affairs preferred.
  • Excellent knowledge of US and international IVD regulations.
  • Strong written and verbal communication skills.
  • High attention to detail.
  • Technical system skills (e.g., MS Office, SharePoint, statistical packages, online research).
  • Ability to manage multiple projects and deadlines.
  • Strong understanding of statistical analysis.
  • Ability to identify compliance risks and escalate when necessary.
  • Prior experience in regulatory submissions (pre-submissions, EUA, 510(k), De      Novo, PMA) for lateral flow and real-time PCR assays is required.


Work Environment
  • Professional office environment with extensive computer-based work.
  • Occasional work in a GMP-regulated manufacturing environment and Biosafety Level 2 (BSL-2) laboratory setting.


Perks & Benefits
  • Medical, dental, vision, life & disability insurance
  • 401(k) + Roth IRA + FSA options
  • 2 weeks paid vacation + 11 paid holidays (including winter break)
  • Competitive pay and growth opportunities
  • Supportive, team-oriented culture focused on innovation and impact


Apply Today

Join a dedicated team committed to advancing diagnostic technologies that improve lives worldwide. Bring your regulatory expertise, collaborative mindset, and passion for quality to help deliver innovative solutions for infectious disease detection and global public health. 

Requirements: