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Raps Regulatory Affairs Jobs (NOW HIRING)

Houston Methodist

$149K - $196K/yr

RAC-DRUG - Regulatory Affairs Certifications Pharmaceuticals (RAPS) - Regulatory Affairs Professionals Society_PSV Preferred * RAC-DEVICE - Regulatory Affairs Certifications Medical Devices (RAPS ...

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How much do raps regulatory affairs jobs pay per hour?

As of Aug 9, 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.

More about Raps Regulatory Affairs jobs
What cities are hiring for Raps Regulatory Affairs jobs? Cities with the most Raps Regulatory Affairs job openings:
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What job categories do people searching Raps Regulatory Affairs jobs look for? The top searched job categories for Raps Regulatory Affairs jobs are:
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, 86% Full Time, 9% Part Time, and 4% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.

Regulatory Affairs Specialist 4

DGN Technologies

Sunnyvale, CA • On-site

Other

Re-posted 15 days ago

Job description

Primary Function of Position

The Sr. Regulatory Affairs primary responsibilities include developing regulatory plans, reviewing design input/output documentation, identification of applicable standards and guidance documents, performing regulatory assessments to determine the impact of design/process changes, preparing regulatory submissions, maintaining regulatory filings and licenses.

Essential Job Duties

• Provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation.

• Determine regulatory pathways and formulate regulatory strategies for the 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 U.S. FDA 510(k) premarket notifications, internal Letters to File, , pre-submissions, Health Canada submissions with minimal supervision.

• Coordinate with technical experts to provide additional data/information requested by regulatory agencies and prepare responses to facilitate regulatory approvals.

• Provide risk-based guidance and regulatory input to projects and issues, ensuring cross- functional alignment and resolution.

• Collaborate with international counterparts to support global regulatory submissions, approvals, and implementation rollouts.

Required Skills and Experience

• Minimum 8 years of regulatory affairs experience working in a medical device company (can be in combination with a regulatory affairs master degree; e.g., Masters in Regulatory Science) • In-depth understanding of US Medical Device regulations, Health Canada guidance and EU MDR.

• Regulatory working knowledge of product lifecycle management, design controls, risk management, verification and validation, and product labeling requirement • Ability to work in a fast-paced environment and handle multiple projects simultaneously

• Strong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation, and regulatory submissions • Team player who seeks to help and learn from colleagues seeing the department success as their own • Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism • Proactively seeks to develop and become well-versed within the regulatory landscape.

Required Education and Training

Minimum B.S. or higher in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or Pharmacy preferred. Non-technical degrees with equivalent complex medical device experience are acceptable.

Working Conditions

None

Preferred Skills and Experience

• RAPS Regulatory Affairs Certification (RAC) is a plus.

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