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How much do raps regulatory affairs jobs pay per hour?

As of Sep 6, 2026, the average hourly pay for raps regulatory affairs 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 RAPS Regulatory Affairs professional?

RAPS Regulatory Affairs professionals are experts who help ensure that products such as pharmaceuticals, medical devices, and biotechnology items comply with all regulations and laws required by government agencies. RAPS stands for the Regulatory Affairs Professionals Society, which is an organization providing education, resources, and certification for regulatory affairs professionals. These professionals play a crucial role in every stage of a product’s lifecycle, from development to market approval, by managing submissions, monitoring compliance, and communicating with regulatory bodies. They also keep up with changing regulations to help companies maintain compliance and avoid penalties.

What are the key skills and qualifications needed to thrive as a RAPS Regulatory Affairs professional?

To succeed in RAPS Regulatory Affairs, you need a strong background in life sciences or related fields, knowledge of regulatory guidelines, and often a RAPS certification such as RAC (Regulatory Affairs Certification). Familiarity with regulatory submission systems, document management tools, and databases is typically required. Excellent analytical thinking, attention to detail, and effective communication are crucial soft skills for interpreting regulations and collaborating with cross-functional teams. These skills ensure compliance with complex regulations, smooth product approvals, and protect organizational interests in the global healthcare market.

What are some common challenges faced by RAPS Regulatory Affairs professionals when working with cross-functional teams?

RAPS Regulatory Affairs professionals often collaborate with teams in R&D, quality assurance, marketing, and manufacturing to ensure products meet regulatory requirements. A common challenge is balancing strict compliance standards with the pace of product development, requiring clear communication and negotiation skills. Additionally, staying updated on evolving regulations and translating technical details for non-regulatory colleagues can be demanding. Building strong relationships and maintaining open communication across departments are essential for success in this role.

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

AspectRaps Regulatory AffairsRegulatory Affairs Specialist
CredentialsTypically requires a degree in life sciences, certifications like RAC beneficialSimilar credentials, often with certifications like RAC or CCRA preferred
Work EnvironmentWorks within pharmaceutical, biotech, or medical device companies, focusing on complianceWorks in similar settings, handling regulatory submissions and compliance tasks
Industry UsageCommonly used in pharmaceutical and biotech industries for regulatory compliance rolesWidely used across healthcare, medical devices, and pharmaceutical sectors

Both roles involve ensuring products meet regulatory standards, but Raps Regulatory Affairs often refers to a broader or more specialized function within regulatory teams, while Regulatory Affairs Specialist is a common job title for professionals handling daily compliance and submission tasks.

Is regulatory affairs a stable career?

Regulatory affairs is generally considered a stable career due to consistent demand in industries such as pharmaceuticals, medical devices, and biotechnology. Professionals in this field often require specialized knowledge, certifications, and stay updated on changing regulations, which supports long-term employment prospects.

Is regulatory affairs high paying?

Regulatory affairs professionals often earn competitive salaries, especially with experience and advanced certifications. Salaries vary by industry, location, and level of responsibility, but the role generally offers a good compensation package compared to many other administrative or compliance positions.

What is the highest paying job in Raps Regulatory Affairs?

The highest paying roles in Regulatory Affairs typically include Senior Director or Vice President positions, which oversee regulatory strategies and compliance at a high level. These roles often require extensive experience, advanced certifications, and leadership skills, and can offer salaries exceeding $150,000 annually depending on the company and location.
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Raps Regulatory Affairs jobs near you
Infographic showing various Raps Regulatory Affairs job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 88% Full Time, 9% Part Time, and 2% Contract. Highlights an 90% Physical, 3% Hybrid, and 7% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.

Regulatory Affairs Specialist

Theragenics Corp

Garland, TX • On-site

$85 - $125/hr

Other

Posted 15 days ago

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Regulatory Affairs Specialist

Full Time Individual Contributor Professional Galt Medical US Texas, Garland, TX, US

4 days ago Requisition ID: 1231

At Theragenics, we're passionate about transforming healthcare and enhancing patient outcomes. Our commitment to innovation drives us to push the boundaries of what's possible, ensuring a brighter future for patients everywhere. Theragenics is a leader in developing medical devices that focus on minimally invasive treatments for cancer, blood vessel procedures, and surgical applications. The company is based in Atlanta, Georgia, and has facilities in Costa Rica, Texas, and Massachusetts. Theragenics proudly operates Arrotek, a visionary medical device design consultancy in the U.S. and Ireland, dedicated to pioneering minimally invasive solutions that enhance lives.

Note: This is a hybrid position.

Role Summary

As a Regulatory Affairs Specialist, you’ll play a pivotal role in driving global regulatory compliance and product submissions, collaborating with cross-functional teams to deliver cutting-edge solutions in medical device regulatory affairs across domestic and international markets.

Key Responsibilities

Regulatory Compliance: Partner with Quality, Engineering, Operations, and Document Control to ensure business compliance with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, EU MDR, MDSAP, and applicable international regulations.

Regulatory Submissions: Coordinate the preparation, assembly, and submission of 510(k)s, Technical Files, Letters to File, Product Registrations, and international market registrations to obtain approvals for product development, clinical trials, and marketing authorizations.

Documentation & Audits: Prepare, review, and submit regulatory documents, maintain up-to-date regulatory files, conduct internal audits, and support customer and regulatory agency audits as needed.

Global Strategy & Guidance: Stay abreast of evolving global regulatory requirements, provide regulatory guidance to project teams, and facilitate communication between internal stakeholders, notified bodies, and regulatory authorities.

QMS Support: Offer support in Quality Management System (QMS) operations, including surveillance, reporting, and label approvals as necessitated.

Qualifications & Skills

Required Qualifications:

Bachelor’s degree in a science or engineering field (such as biology, chemistry, or pharmacy).

3 to 5 years of working experience in a regulated field like clinical research or medical manufacturing.

Experience working with international manufacturing locations.

Direct working experience with FDA regulations, EU MDR, and MDSAP.

Bilingual fluency in both English and Spanish (written and verbal).

Preferred Qualifications:

Advanced degree in a related science or engineering field.

Experience with Class II and/or Class III medical devices.

Experience supporting manufacturing operations in Latin America.

Regulatory Affairs Certification (RAC) and/or Regulatory Affairs Professionals Society (RAPS) membership.

Success Measures

Within the first 12 months, the successful candidate will:

Significantly progress EU MDR submissions.

Identify post-submission continuous improvement actions.

Maintain successful FDA, ISO, and customer audit outcomes with no critical findings.

Why Join Us

Purpose-driven work: Directly contribute to the approval and delivery of life-changing medical technologies.

Innovative projects: Engage with complex global markets, EU MDR initiatives, and class-leading medical devices.

Collaborative culture: Work side-by-side with cross-functional teams spanning quality, engineering, and international operations.

Career growth: Expand your regulatory expertise across multiple global jurisdictions and regulatory frameworks.

Competitive benefits: Enjoy a comprehensive total rewards package designed to support you and your family.

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