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Assistant Regulatory Writing Jobs (NOW HIRING)

Prometrika LLC

Senior Medical Writer

Cambridge, MA · On-site

$134K - $162K/yr

The Senior Medical Writer will also assist with and contribute to departmental leadership ... Minimum of 6 years of experience in medical writing with a minimum 4 years regulatory writing in ...

Life's WORC

REGULATORY AFFAIRS ADMIN ASST

Garden City, NY · On-site

$45K - $48K/yr

Excellent verbal & written communication skills, excellent organizational & time management skills ... regulatory timeframe. * Assist with creation of presentations for the Incident Review Committee ...

Berlin Heart Inc

Jr RA/QA Associate

The Woodlands, TX · On-site

The Junior Quality/Regulatory Affairs Associate will also assist Regulatory Affairs in producing ... written communication skills, collaboratively works with others, and operate ethically and with ...

Tandem Clinical Research

Regulatory Specialist

Document Preparation & Submission: Assist in preparing and submitting regulatory documents to IRBs ... Strong written and verbal communication skills * Professionalism when interacting with internal and ...

BERJE INCORPORATED

Regulatory Specialist

Carteret, NJ

$28.36 - $42.20/hr

Along with the entire Regulatory team, assist with ourHACCP plan and communicate changes with ... English language reading, writing, and speaking * Computer skills including MS Word & Excel

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How much do assistant regulatory writing jobs pay per year?

As of Jun 21, 2026, the average yearly pay for assistant regulatory writing in the United States is $58,981.00, according to ZipRecruiter salary data. Most workers in this role earn between $41,000.00 and $77,000.00 per year, depending on experience, location, and employer.
What are the most commonly searched types of Regulatory Writing jobs? The most popular types of Regulatory Writing jobs are:
Assistant Regulatory Writing jobs near you
Infographic showing various Assistant Regulatory Writing job openings in the United States as of June 2026, with employment types broken down into 2% As Needed, 63% Full Time, 33% Part Time, and 2% Contract. Highlights an 98% Physical, 1% Hybrid, and 1% Remote job distribution, with an average salary of $58,981 per year, or $28.4 per hour.

Regulatory Affairs Specialist I

Highridge Medical

Westminster, CO • On-site

Full-time

Posted 7 days ago

Job description

Regulatory Affairs Specialist I
Principal Duties and Responsibilities:
  • Assist with assembly, distribution, storage and tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process. May author and publish electronic submissions.

  • Respond to requests from foreign government and/or distributors as needed

  • Assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products

  • Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products

  • Evaluate risk of proposed regulatory strategies; may offer solutions

  • Reviews proposed labeling for compliance with applicable global regulations

  • Writes and manages the development of package inserts

  • Reviews and evaluations promotion and advertising material for compliance with applicable regulations

  • Reviews proposed product changes for impact on regulatory status of the product

  • Communicates with regulatory and governmental agencies with supervision

  • Applies FDA regulations to business practices and provides regulatory input, advice and guidance to design teams.

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.
Expected Areas of Competence (i.e., knowledge, skills, and abilities)
  • Strong writing, communication, and interpersonal skills

  • Strong attention to detail; ability to multi-task and balance competing priorities

  • Knowledge of overall business environment, the orthopaedic industry, and the marketplace

  • Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as needed, based on functional area /

  • Ability to building relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels

  • Knowledge of FDA, EU, and other regulatory body regulations

  • Ability to identify risk in Regulatory strategies

  • Strong problem solving skills

  • Effective negotiating skills

  • Basic computer skills, including Microsoft Office Suite

Education/Experience Requirements
  • Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred

  • A minimum of one year of experience in orthopaedic or medical device industry preferred

  • A minimum of 3 years of experience in Regulatory Affairs, Engineering, Quality, or related field required

  • Regulatory Affairs Certification (US or EU) preferred

  • A combination of education and experience may be considered

Travel Requirements
Up to 15%

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