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Medical Device Regulatory Jobs (NOW HIRING)

Pacer Group

Regulatory Affairs Specialist

Raleigh, NC · On-site

Knowledge of medical device regulations and governing laws such as 21 CFR 814, 21 CFR 814, 21 CFR 820. * Strong analytical, investigative, and organizational skills. Demonstrate curiosity preferred.

Marmon

Regulatory Associate

Hillsboro, OR

Utilizes computer and software proficiencies to create, coordinate, procure and/or maintain data and documentation to support OUS medical device registration. The Regulatory Associate also employs an ...

AstrixTechnology LLC

Be Seen First

Medical Device Assembler

North Tonawanda, NY · On-site

$19/hr

... regulatory advisory services and staffing solutions to the scientific community. We can assist in ... Medical device, Petrochemical and Clinical Research.

CorDx

Regulatory Affairs Manager (Atlanta)

Atlanta, GA · On-site

... care medical device solutions used in the detection of infectious disease such as COVID-19 ... Regulatory Affairs Manager Location: Onsite - Atlanta, GA Position Summary: The Regulatory Affairs ...

CorDx

Regulatory Affairs Manager (Atlanta)

Atlanta, GA · On-site

... care medical device solutions used in the detection of infectious disease such as COVID-19 ... Regulatory Affairs Manager Location: Onsite - Atlanta, GA Position Summary: The Regulatory Affairs ...

CorDx

Regulatory Affairs Manager (Atlanta)

Atlanta, GA · On-site

... care medical device solutions used in the detection of infectious disease such as COVID-19 ... Regulatory Affairs Manager Location: Onsite - Atlanta, GA Position Summary: The Regulatory Affairs ...

Medtronic

Regulatory Affairs Specialist

Moundsview, MN · On-site

Minimum 2 Years of medical device regulatory experience with Bachelor's degree * Or minimum 0 Years of medical device regulatory experience with an advanced degree Nice To Have * Experience working ...

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Medical Device Regulatory information

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$18

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$62

How much do medical device regulatory jobs pay per hour?

As of Jun 16, 2026, the average hourly pay for medical device regulatory 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.

Is medical device regulatory affairs a good career?

Medical device regulatory affairs is a growing field that involves ensuring compliance with industry standards and government regulations for medical devices. It requires knowledge of regulations such as FDA or ISO standards and often involves collaboration with engineering, quality assurance, and clinical teams. The role offers stability, specialized expertise, and opportunities for advancement in the healthcare industry.

What are some common challenges faced by professionals in Medical Device Regulatory roles, and how can they be addressed?

Professionals in Medical Device Regulatory roles often face challenges such as keeping up with constantly evolving global regulations, coordinating with cross-functional teams, and ensuring timely submissions for product approvals. Navigating differing requirements across regions (e.g., FDA, EU MDR, TGA) can be complex and demands a proactive approach to regulatory intelligence. Building strong communication channels with R&D, quality, and clinical teams, as well as staying engaged with regulatory updates and training, can help manage these challenges effectively.

What is the highest paying job in regulatory affairs?

The highest paying roles in regulatory affairs are typically senior executive positions such as Vice President or Director of Regulatory Affairs, which can earn six-figure salaries. These roles often require extensive experience, advanced certifications like RAC, and leadership skills in managing compliance strategies for medical devices or pharmaceuticals.

What does regulatory do in medical devices?

A regulatory professional in medical devices ensures that products comply with applicable laws, standards, and regulations for safety and effectiveness. They prepare and submit documentation for approvals, manage quality systems, and stay updated on evolving regulatory requirements to facilitate market access and maintain compliance.

What are Medical Device Regulatory professionals?

Medical Device Regulatory professionals are specialists who ensure that medical devices comply with the laws and regulations of the countries where they are marketed and sold. Their responsibilities include preparing and submitting documentation to regulatory authorities, monitoring changes in regulatory requirements, and collaborating with product development teams to ensure ongoing compliance. These professionals play a critical role in obtaining approvals or clearances for medical devices, enabling them to reach the market safely and efficiently. They also contribute to post-market surveillance and handle communication with regulators regarding product modifications or issues.

What is the difference between Medical Device Regulatory vs Medical Device Quality Assurance?

AspectMedical Device RegulatoryMedical Device Quality Assurance
CertificationsRegulatory Affairs Certification (RAC), ISO 13485 Lead AuditorISO 13485 Lead Auditor, CQE
Work EnvironmentRegulatory agencies, compliance departments, documentation reviewManufacturing sites, quality control labs, audit environments
Employer & Industry UsageMedical device companies, regulatory consulting firmsManufacturers, quality management organizations

Medical Device Regulatory professionals focus on ensuring products meet legal and regulatory requirements for market approval, while Medical Device Quality Assurance specialists concentrate on maintaining product quality through standards and audits. Both roles are essential in the medical device industry and often collaborate to ensure compliance and safety.

What are the key skills and qualifications needed to thrive as a Medical Device Regulatory Specialist, and why are they important?

To thrive as a Medical Device Regulatory Specialist, you need a thorough understanding of medical device regulations, quality management systems, and often a degree in life sciences or engineering. Familiarity with regulatory submission systems (like FDA eSubmitter), ISO 13485, and certifications such as RAC (Regulatory Affairs Certification) are highly valued. Attention to detail, strong communication, and problem-solving skills help ensure compliance and effective collaboration with cross-functional teams. These capabilities are critical for navigating complex regulatory landscapes and ensuring safe, timely product approvals.

Which is better, RA or QA?

In the medical device regulatory field, Regulatory Affairs (RA) professionals focus on ensuring compliance with regulations and obtaining approvals from agencies like the FDA, while Quality Assurance (QA) staff concentrate on maintaining product quality through testing, audits, and process controls. Both roles are essential and often work together; the choice depends on whether you prefer navigating regulatory policies or ensuring product quality through internal processes. Certifications like RAC or ISO 13485 knowledge can enhance career prospects in either area.
More about Medical Device Regulatory jobs
What cities are hiring for Medical Device Regulatory jobs? Cities with the most Medical Device Regulatory job openings:
What states have the most Medical Device Regulatory jobs? States with the most job openings for Medical Device Regulatory jobs include:
What job categories do people searching Medical Device Regulatory jobs look for? The top searched job categories for Medical Device Regulatory jobs are:
Medical Device Regulatory jobs near you
Infographic showing various Medical Device Regulatory job openings in the United States as of June 2026, with employment types broken down into 14% Full Time, 83% Part Time, 2% Contract, and 1% Nights. Highlights an 95% Physical, 1% Hybrid, and 4% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.
Regulatory Affairs Specialist (Bedford, MA)

Regulatory Affairs Specialist (Bedford, MA)

CEDENT

Bedford, MA • On-site

Other

Posted 26 days ago

Job description

Responsibilities: Determine and document change assessments for US Class II devices to ensure compliance with the US regulation. Plan and prepare submissions for US Class II devices, including creating, translating, revising, reviewing, and compiling documents, as well as responding to questions and requests from the FDA. Determine and document change assessments for EU Class III & IIb devices to ensure compliance with the EU Medical Device Regulation.

Plan and prepare submissions for EU Class III & IIb devices, including creating, translating, revising, reviewing, and compiling documents, as well as responding to questions and requests from the Notified Body. Support submission and maintenance of product registrations in markets worldwide. Support product registrations, including creating, revising, reviewing and compiling documents for submission to regulatory authorities, as well as assisting in responding to questions and requests from such authorities.

Assist in external audits by supporting responses to auditor questions and requests. Keep abreast of new or changed regulations and standards and perform gap analyses. Perform additional duties as assigned.

Qualifications: (REQUIRED) Bachelor's degree, preferably in the life sciences; advanced degree a plus. (REQUIRED) At least 3 years of experience in medical device field, including hands-on experience with submissions. Experience in regulatory submissions to medical device regulatory bodies a plus; e.g., FDA, Health Canada, ANVISA/INMETRO, EU NB, MHRA, Swissmedic, NMPA, PMDA, MFDS, and TGA

Experience with software-driven and electro-mechanical medical devices a plus. Strong knowledge of US and international requirements for regulatory submissions and maintenance of medical devices. Team player with ability to work independently in hybrid/in-person setting (Bedford, MA).

Excellent and effective written and verbal communication skills. Excellent interpersonal skills, good judgment and analytical skills. Effective time management and organizational skills.

Consistent, quality work and commitment to follow-through.

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About Cedent

Sourced by ZipRecruiter

CEDENT strives to attract and retain the best people and provide an environment where they can all develop professionally and build a rewarding career. As a result, we create an inclusive environment that is rich in diversity, acknowledges each individual's uniqueness and promotes respect, personal achievement and stewardship. Our clients are global and so is CEDENT. We build and maintain a global workforce that includes people from different backgrounds, with a vast range of skills and experience all united by a common culture and commitment to help our clients achieve high performance. Cultivating a diverse workforce and inclusive work environment makes business sense. Our peoples varied skills are the talent engine that powers CEDENT, enabling it in turn to deliver the innovative solutions that help our clients outperform competitors.

Industry

It services

Company size

11 - 50 Employees

Headquarters location

Plano, TX, US

Year founded

2008

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