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Regulatory Affairs Certification Jobs (NOW HIRING)

Aequor

Regulatory Affairs Specialist 1 Year Contract Warsaw, IN (100% Onsite) Duties Responsible for ... Affairs Certification (US or EU) preferred A combination of education and experience may be ...

RXinsider LTD.

$110 - $135/hr

ASQ certifications, Regulatory Affairs Certification (RAC), ISO 13485 Lead Auditor, Lean Six Sigma, or PMP certification. Core Competencies * Strategic Leadership * Regulatory Affairs * Quality ...

Advita Ortho

$140 - $190/hr

Regulatory Affairs Certification (RAC) preferred Functional/Technical Knowledge, Skills and Abilities Required: * Proficiency with windows-based office productivity tools (Microsoft Office) #J-18808 ...

Advita Ortho

Sr Manager, Regulatory Affairs

Regulatory Affairs Certification (RAC) preferred Functional/Technical Knowledge, Skills and Abilities Required: * Proficiency with windows-based office productivity tools (Microsoft Office)

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How much do regulatory affairs certification jobs pay per hour?

As of Sep 6, 2026, the average hourly pay for 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.

What is regulatory affairs certification?

Regulatory Affairs Certification (RAC) is a professional credential awarded to individuals who demonstrate knowledge and expertise in regulatory affairs, particularly in industries such as pharmaceuticals, medical devices, and biotechnology. Earning the RAC shows that a professional understands the regulations and guidelines governing the development, approval, and marketing of healthcare products. The certification is offered by the Regulatory Affairs Professionals Society (RAPS) and is recognized internationally as a mark of regulatory competence and commitment to professional development.

What are the key skills and qualifications needed to thrive in a regulatory affairs certification role, and why are they important?

To excel in a Regulatory Affairs Certification role, you need a solid understanding of regulatory guidelines, compliance standards, and industry-specific regulations, often supported by a relevant degree and RAC certification. Familiarity with regulatory submission systems, document management software, and databases like FDA’s eCTD is typically required. Strong attention to detail, analytical thinking, and effective communication are vital soft skills in this position. These qualifications ensure accurate submissions, smooth regulatory processes, and help maintain compliance in highly regulated industries.

What are some common challenges faced by professionals in regulatory affairs certification roles, and how can they be addressed?

Professionals in Regulatory Affairs Certification often encounter challenges such as keeping up with constantly evolving regulations across different markets and ensuring timely compliance for product approvals. They must also manage complex documentation and coordinate between internal teams and regulatory agencies. Staying organized, building strong cross-functional relationships, and engaging in continuous professional development can help address these challenges and support efficient regulatory submissions.

What is the difference between Regulatory Affairs Certification vs Regulatory Affairs Specialist?

AspectRegulatory Affairs CertificationRegulatory Affairs Specialist
CredentialsCertification from a recognized body (e.g., RAC)Typically a degree in life sciences; experience varies
Work EnvironmentRegulatory agencies, consulting firms, or corporate compliancePharmaceutical, biotech, or medical device companies
Industry UsageProfessional credential for regulatory rolesJob title for regulatory compliance roles

Regulatory Affairs Certification (RAC) is a professional credential demonstrating expertise in regulatory processes, while a Regulatory Affairs Specialist is a job role that may or may not require certification. Certification can enhance career prospects, but many specialists gain experience through education and on-the-job training.

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What states have the most Regulatory Affairs Certification jobs?

States with the most job openings for Regulatory Affairs Certification jobs include:

What job categories do people searching Regulatory Affairs Certification jobs look for?

The top searched job categories for Regulatory Affairs Certification jobs are:

Regulatory Affairs Certification jobs near you
Infographic showing various Regulatory Affairs Certification job openings in the United States as of August 2026, with employment types broken down into 2% As Needed, 73% Full Time, 18% Part Time, and 7% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $118,493 per year, or $57 per hour.

Staff Regulatory Affairs Specialist (Pharmaceutical Products)

Stryker Group

Cary, IL • On-site

$105 - $176/hr

Other

Posted 5 days ago

Job description

Stryker is seeking a Staff Regulatory Affairs Specialist, (Pharmaceutical Products) to join our Medical Division. This is a hybrid role based in Cary, IL.

As the Staff Regulatory Affairs Specialist, you will provide information used to evaluate proposed products for regulatory classification and jurisdiction. You will research requirements (local, national, international), applicable guidance and standards and options of regulatory submissions, approval pathways, and compliance activities.

What you will do

  • Prepare and author annual reports and other regulatory submissions required for approved pharmaceutical products.

  • Assess product, process, and manufacturing changes to determine appropriate regulatory reporting requirements and submission pathways.

  • Develop and submit amendments, supplements, and other regulatory filings in accordance with applicable regulations and guidance.

  • Review technical documentation and regulatory content to ensure accuracy, completeness, and submission readiness.

  • Research regulatory requirements, standards, guidance documents, and approval pathways to support product development and lifecycle management.

  • Communicate with regulatory agencies regarding submission strategies, regulatory pathways, submission status, and responses to agency inquiries.

  • Partner with engineering, quality, clinical, manufacturing, and marketing teams to support regulatory objectives during product development and sustaining activities.

  • Develop and communicate regulatory guidance, requirements, and compliance considerations to support business and project goals.

What you needRequired

  • Bachelor's degree in Science, Engineering, Regulatory Affairs, or a related discipline.

  • Minimum 4 years of experience in an FDA-regulated or other highly regulated industry.

  • Minimum 2 years of Regulatory Affairs experience within the medical device and/or pharmaceutical industry.

  • Experience reviewing regulatory requirements and assessing regulatory impact of product, process, or manufacturing changes.

  • Experience preparing, authoring, or supporting drug regulatory submissions, including submissions for product approvals, post-approval changes, or lifecycle management activities.

Preferred

  • Regulatory Affairs Certification (RAC) or Master's degree in Regulatory Affairs or a related field.

  • Experience preparing or supporting international regulatory submissions and registrations.

  • Experience interacting directly with regulatory agencies.

  • Regulatory Affairs Certification (RAC) or Master's degree in Regulatory Affairs or a related field.

  • US10: $105,300 - $175,500 USD Annual
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