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Medical Device Regulatory Jobs (NOW HIRING)

Kellton Tech

Medical Device Assembler

Madison, WI · On-site

$23 - $24/hr

Ensure work is completed in compliance with company quality system and medical device regulations. Essential Functions Assemble and test finished and semi-finished medical devices per established ...

Heraeus

Regulatory Affairs Specialist

Minneapolis, MN · On-site +1

$110K - $120K/yr

Regulatory Affairs Specialist Fridley About Heraeus Making displays foldable? Helping hearts beat ... Review international submissions to be submitted by our medical device company customers/partners.

Open Scientific

Regulatory Manager

Sunrise, FL

Develop medical device regulatory submissions in accordance with FDA requirements (e.g., pre-submissions, original IDEs, IDE supplements, 6-month Investigator Lists, original PMAs, PMA supplements ...

Robert Half

Regulatory Specialist

Newberg, OR · On-site

The ideal candidate brings strong knowledge of global medical device regulations and can manage regulatory activities throughout the product lifecycle while supporting audits, labeling review, and ...

CEDENT

Regulatory Affairs Specialist

Bedford, MA

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 ...

Kellton Tech

Medical Device Technician

Madison, WI · On-site

$38K - $48K/yr

Ensure work is completed in compliance with company quality system and medical device regulations. Essential Functions * Assemble, test, and repair work per established work instructions, policies ...

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Medical Device Regulatory information

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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.

Medical Device Regulatory Specialist

Google

Washington, DC • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 11 days ago

Google rating

8.8

Company rating: 8.8 out of 10

Based on 92 frontline employees who took The Breakroom Quiz

32nd of 190 rated software companies

Job description

info_outline
X In accordance with Washington state law, we are highlighting our comprehensive benefits package, which is available to all eligible US based employees. Benefits for this role include:
  • Health, dental, vision, life, disability insurance
  • Retirement Benefits: 401(k) with company match
  • Paid Time Off: 20 days of vacation per year, accruing at a rate of 6.15 hours per pay period for the first five years of employment
  • Sick Time: 40 hours/year (increased to 69 hours/year for Seattle) including 5 discretionary sick days per instance
  • Maternity Leave (Short-Term Disability Baby Bonding): 28-30 weeks
  • Baby Bonding Leave: 18 weeks
  • Holidays: 13 paid days per year

Minimum qualifications:
  • Master's degree in Engineering, a related technical field, or equivalent practical experience.
  • 5 years of experience in regulatory affairs and engagement with global regulatory bodies.
  • Experience with medical device standards and software as a medical device frameworks.
  • Experience monitoring regulatory developments and composing white papers or policy briefs.

Preferred qualifications:
  • Experience at leading med-tech firms, having served as the Directly Responsible Individual (DRI) for innovative product launches.
  • Experience within digital health or AI policy space, including deep understanding of how generative models are integrated into clinical settings.
  • Familiarity with Cloud-native Quality Management Systems (ISO 13485) and AI-specific quality standards (ISO 42001).
  • Deep understanding of international harmonization efforts such as IMDRF and the processes regulators use to develop policy and guidance in major markets like the US and EU.
  • Proven track record of contributing to the creation of international standards through organizations such as ISO/IEC and AAMI.

About the job
The Digital Health Regulatory Quality and Strategy (DHRQS) team serves as the advisors helping Google navigate the complex and evolving global health regulatory landscape. Our team is at the forefront of defining how AI can safely and effectively transform healthcare. We focus on three primary pillars. We provide the regulatory strategy and operational infrastructure to help product teams across Google build and launch regulated products globally. We safeguard Google's core platforms and general-purpose models from being unintentionally regulated or exposed to liability, ensuring a clear separation between regulated features and core business services and we actively partner with global health authorities to shape international standards and national policies, ensuring AI regulations balance innovation with safety.
In this role, you will operate at the nexus of the health ecosystem, technological advancement, and regulatory expertise to steer Google's platforms in supporting billions of individuals throughout their health experiences. You will work with the engineers and product builders along with clinicians who are passionate about applying technology in health.
Google for Health is a company-wide effort to help billions of people be healthier. We work toward this vision by meeting people in their everyday moments and empowering them to stay healthy and partnering with care teams to provide more accurate and accessible care. Our teams are applying our expertise and technology to improve health outcomes globally - with high-quality information and tools to help people manage their health and wellbeing, solutions to transform care delivery, research to catalyze the use of artificial intelligence for the screening and diagnosis of disease, and data and insights to the public health community.Individual pay is determined by factors including job-related skills, experience, and relevant education or training.
US: $144000 - $209000 (USD) 15% bonus target bonus equity benefits
Learn more about benefits at Google .
Responsibilities
  • Monitor and analyze legislative and regulatory developments related to AI and healthcare policy. Coordinate and facilitate professional regulatory engagements with regulators and policy makers and the preparation of formal submissions.
  • Maintain expertise regarding emerging regulatory frameworks as they pertain to Medical Devices and Software as a Medical Device (SaMD).
  • Liaise with engineering and clinical functions at Google to align regulatory claims with necessary evidence. Provide support to the Leadership during high-level meetings with regulators and contribute to international standards development.
  • Conduct comprehensive monitoring and analysis of legislative and regulatory shifts in AI and healthcare policy.
  • Compose authoritative white papers, policy briefs, and participate in formal responses to public consultations initiated by regulatory entities or standards development organizations.

Information collected and processed as part of your Google Careers profile, and any job applications you choose to submit is subject to Google's Applicant and Candidate Privacy Policy .
Google is proud to be an equal opportunity and affirmative action employer. We are committed to building a workforce that is representative of the users we serve, creating a culture of belonging, and providing an equal employment opportunity regardless of race, creed, color, religion, gender, sexual orientation, gender identity/expression, national origin, disability, age, genetic information, veteran status, marital status, pregnancy or related condition (including breastfeeding), expecting or parents-to-be, criminal histories consistent with legal requirements, or any other basis protected by law. See also Google's EEO Policy , Know your rights: workplace discrimination is illegal , Belonging at Google , and How we hire .
If you have a need that requires accommodation, please let us know by completing our Accommodations for Applicants form .
Google is a global company and, in order to facilitate efficient collaboration and communication globally, English proficiency is a requirement for all roles unless stated otherwise in the job posting.
To all recruitment agencies: Google does not accept agency resumes. Please do not forward resumes to our jobs alias, Google employees, or any other organization location. Google is not responsible for any fees related to unsolicited resumes.
Equity is granted exclusively and discretionarily by Alphabet Inc. on the basis of an agreement concluded between you and Alphabet Inc. Alphabet Inc. is your sole contractual partner with respect to equity grants. GSU grants are not guaranteed, are discretionary, are subject to approval by the Alphabet Inc. board of directors or its delegate, the terms of the relevant Alphabet Inc. stock plan, and your grant agreement. They have no impact on statutory payments. Current or past grants do not confer an acquired right.

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