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Regulatory Affairs Associate Jobs (NOW HIRING)

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 ...

BPI Labs, LLC

Regulatory Affairs Associate

Largo, FL · On-site

BPI Labs, a pharmaceutical manufacturing company based in Largo, FL, is seeking a Regulatory Affairs Associate, Licensing & Compliance to manage end-to-end licensing activities required for ...

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How much do regulatory affairs associate jobs pay per hour?

As of Jul 14, 2026, the average hourly pay for 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 a Regulatory Affairs Associate?

A regulatory affairs associate helps medical and pharmaceutical companies navigate regulatory approval processes so that products conform to all local, state, and federal regulations. As a regulatory affairs associate, you work with a team to obtain approval for products, maintain database systems for relevant information, and create reports required by federal or government agencies. You stay abreast of developments in legislation and regulation that may affect your company, and advise others on best practices for product development within a regulated framework.

What are Regulatory Affairs Associates?

Regulatory Affairs Associates are professionals who help ensure that companies comply with all regulations and laws applicable to their products, particularly in industries like pharmaceuticals, medical devices, and biotechnology. They are responsible for preparing and submitting documentation to regulatory agencies, maintaining records, and assisting with product approvals. Their work is crucial for bringing safe and effective products to market while meeting all legal requirements.

What are some common challenges Regulatory Affairs Associates face when coordinating with cross-functional teams?

Regulatory Affairs Associates often collaborate closely with departments such as research and development, quality assurance, and marketing. A common challenge is ensuring all stakeholders understand and adhere to regulatory requirements, which may change frequently. Balancing project timelines with the need for accurate and compliant documentation can also be demanding, especially when teams have competing priorities. Effective communication and proactive planning are key to navigating these challenges successfully.

What are the key skills and qualifications needed to thrive as a Regulatory Affairs Associate, and why are they important?

To thrive as a Regulatory Affairs Associate, you need a solid background in life sciences or related fields, attention to detail, and knowledge of regulatory guidelines and standards. Familiarity with submission management systems, regulatory databases, and certifications such as RAC (Regulatory Affairs Certification) are highly valued. Strong organizational skills, effective communication, and the ability to work collaboratively are important soft skills in this role. These abilities ensure accurate documentation, timely regulatory submissions, and successful navigation of complex compliance requirements.
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Regulatory Affairs Associate jobs near you
Infographic showing various Regulatory Affairs Associate job openings in the United States as of July 2026, with employment types broken down into 77% Full Time, 4% Temporary, and 19% Contract. Highlights an 93% In-person, and 7% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.
Regulatory Affairs Associate

Regulatory Affairs Associate

Intellectt INC

Santa Clara, CA • On-site

Contractor

Re-posted 23 days ago

Job description

Job Title: Regulatory Affairs Associate

Location: Santa Clara, CA

Duration: 12 Months

Schedule: 8:00 AM – 5:00 PM

Position Overview

The Regulatory Affairs Associate will be responsible for supporting regulatory strategy, submissions, and compliance activities for Class III implantable medical devices. This role requires strong expertise in FDA regulatory pathways, labeling requirements, and PMA supplement submissions. The candidate will work cross-functionally with engineering, quality, and manufacturing teams to ensure regulatory compliance throughout the product lifecycle.

Key Responsibilities

  • Author, review, and submit PMA supplements, including:
    • 30-Day Notices
    • Real-Time Reviews
    • 180-Day Supplements
    • Annual Reports
  • Manage and execute regulatory labeling activities, including addendum and supplemental labeling updates
  • Review and approve:
    • Engineering study protocols and reports
    • Validation study protocols and reports
    • Manufacturing changes for Class III implantable devices
  • Ensure compliance with FDA PMA guidance documents and CFR regulations
  • Serve as a liaison for regulatory authority interactions, including submission handling and follow-ups
  • Collaborate with cross-functional teams to support product development and change management
  • Provide regulatory guidance and may lead or direct the work of junior team members

Required Qualifications

  • Minimum 5+ years of experience in Regulatory Affairs
  • Strong experience with Class III implantable medical devices
  • Proven track record of successful PMA supplement authoring, submission, and approvals
  • Hands-on experience with regulatory labeling (addendum, supplemental, and change execution)
  • Solid understanding of FDA regulations and medical device quality systems
  • Ability to manage multiple projects with a high degree of autonomy and judgment

Preferred Skills

  • Experience working in a highly regulated medical device environment
  • Strong analytical, documentation, and communication skills
  • Ability to work independently and lead cross-functional initiatives