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Manager Rac Regulatory Affairs Certification Jobs

RED

CMS Chemical Regulatory Manager

Foothill Ranch, CA · On-site

$105K - $120K/yr

RED Digital Cinema is seeking a Chemical Regulatory Manager who will be responsible for ensuring ... Regulatory Affairs Certification (RAC) * Certified Chemical Professional (CCP) Location: Foothill ...

Oterra

Regulatory Affairs Manager

Sturtevant, WI

Regulatory Affairs Certification (RAC) or equivalent professional certification. * Previous people management experience. * Experience with color additive petitions, GRAS notifications, novel ...

New

Dentsply Sirona

Regulatory Affairs Manager

This role manages and submits 510ks for the products and manages communications with FDA including ... Regulatory Certification (such as RAC from the Regulatory Affairs Professionals Society) or Master ...

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How much do manager rac regulatory affairs certification jobs pay per hour?

As of Aug 7, 2026, the average hourly pay for manager rac regulatory affairs certification in the United States is $56.97, according to ZipRecruiter salary data. Most workers in this role earn between $42.07 and $66.59 per hour, depending on experience, location, and employer.

Is regulatory affairs a good career choice?

Regulatory affairs is a stable and growing field that involves ensuring compliance with industry regulations, often requiring certifications such as RAC. It offers opportunities in industries like pharmaceuticals, medical devices, and biotechnology, with roles that typically involve cross-functional collaboration and knowledge of legal and scientific standards.

How to become a manager RAC regulatory affairs certification?

To become a manager in RAC (Regulatory Affairs Certification), candidates typically need a bachelor's degree in a related field such as life sciences or pharmacy, along with several years of experience in regulatory affairs. Obtaining the RAC certification from a recognized organization demonstrates expertise and can enhance career prospects; it involves passing an exam that covers regulatory principles, laws, and procedures. Developing skills in regulatory strategy, compliance, and documentation is essential for advancement to a managerial role.
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Manager Rac Regulatory Affairs Certification jobs near you
Infographic showing various Manager Rac Regulatory Affairs Certification job openings in the United States as of August 2026, with employment types broken down into 88% Full Time, 11% Part Time, and 1% Contract. Highlights an 85% Physical, 2% Hybrid, and 13% Remote job distribution, with an average salary of $118,493 per year, or $57 per hour.

Senior Regulatory Affairs Specialist (Hybrid - Sunnyvale, CA)

BBG Ventures, LLC

Sunnyvale, CA • On-site

$100 - $130/hr

Other

Medical, Dental, Vision, Retirement

Posted 2 days ago

New

Job description

Overview

Our Customer is a corporation that develops, manufactures, and markets robotic products designed to improve clinical outcomes of patients through minimally invasive surgery. Founded in 1995, their goal was to create innovative, robotic‑assisted systems that help empower doctors and hospitals to make surgery less invasive than an open approach. Working with top medical professionals, they continue to develop new minimally invasive surgical platforms and future diagnostic tools to solve complex healthcare challenges worldwide.

Position

Senior Regulatory Affairs Specialist (Contract Basis) – Hybrid (3 days on‑site, 2 days remote per week) located in Sunnyvale, CA.

Responsibilities
  • Provide regulatory guidance to product teams and develop regulatory plans.
  • Review and approve product design control documentation.
  • Determine regulatory pathways and formulate regulatory strategies for U.S. and Canadian markets.
  • Assess regulatory impact on design, materials, labeling, packaging, manufacturing processes, and facility changes.
  • Influence and lead global regulatory strategies.
  • Author and lead regulatory documentation and submissions, including FDA 510(k) pre‑market notifications, Letters to File, pre‑submissions, and Health Canada submissions.
  • Coordinate with technical experts to gather additional data and prepare responses to regulatory agency requests.
  • Provide risk‑based regulatory guidance to projects and issues, ensuring cross‑functional alignment and resolution.
  • Collaborate with international counterparts to support global regulatory submissions, approvals, and implementation rollouts.
  • Maintain regulatory filings and licenses.
Skills and Qualifications
  • Minimum 8 years of regulatory affairs experience in a medical device environment.
  • Strong understanding of U.S. medical device regulations, Health Canada guidance, and EU MDR.
  • Strong knowledge of product lifecycle management, design controls, risk management, verification and validation, and product labeling requirements.
  • Experience preparing regulatory submissions, including FDA 510(k) submissions.
  • Strong ability to assess the regulatory impact of design and process changes.
  • Ability to manage multiple projects in a fast‑paced environment.
  • Strong verbal and written communication skills.
  • Ability to translate technical documentation into internal documentation and regulatory submissions.
  • Strong interpersonal, negotiation, and influencing skills.
  • Strong collaboration and cross‑functional partnership skills.
  • Proactive mindset with commitment to staying current on regulatory landscape developments.
  • Bachelor’s degree or higher in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Pharmacy, or equivalent experience.
Preferred Qualifications
  • Master’s degree in Regulatory Science or related field.
  • Regulatory Affairs Professionals Society Regulatory Affairs Certification (RAC).
Benefits

Contractor benefits available through a third‑party Employer of Record, including Medical, Dental, Vision, and 401(k). Salary range is competitive, with most candidates hired at the median of the range based on experience and qualifications.

Equal Opportunity Employer

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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