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Fda Regulatory Affairs Associate Jobs (NOW HIRING)

EKF Diagnostics

Regulatory Affairs Associate

Boerne, TX · On-site

Regulatory Affairs Associate EKF is seeking a Regulatory Affairs Associate , based in Boerne, TX, ... with FDA and international regulations. Candidates should have experience in regulatory affairs ...

PrideStaff

Regulatory Affairs Associate

Tustin, CA · On-site

$32 - $36/hr

Regulatory Affairs Associate for a biotechnology company located in Tustin. Temporary to Hire ... Support product registrations and regulatory submissions to FDA and other regulatory bodies ...

Viltis

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Regulatory Affairs Associate - Medical Devices / IVDR

South Portland, ME · On-site

$20 - $23/hr

Regulatory Affairs Associate - Medical Devices / IVDR Location: South Portland, ME Schedule: Monday ... Exposure to IVD products, IVDR, FDA regulations, ISO standards, or medical device regulatory ...

Zymo Research

Regulatory Affairs Associate

Tustin, CA · On-site

$68K - $75K/yr

The Regulatory Affairs Associate is an entry-level position for an individual committed to ... Support product registrations and regulatory submissions to FDA and other regulatory bodies ...

RXinsider LTD.

Support interaction with FDA and other regulatory agencies for assigned commercial products ... affairs. * Combination of education and applicable job experience may be considered. * Excellent ...

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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

Piscataway, NJ • On-site

Stark Pharma Solutions Inc
See more jobs at Stark Pharma Solutions Incexternal

Contractor

Re-posted 10 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.