Experience with medical device standards and software as a medical device frameworks. * Experience monitoring regulatory developments and composing white papers or policy briefs. Preferred ...
Experience with medical device standards and software as a medical device frameworks. * Experience monitoring regulatory developments and composing white papers or policy briefs. Preferred ...
FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations, and standards. Company Overview At FUJIFILM Healthcare Americas ...
FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations, and standards. Company Overview At FUJIFILM Healthcare Americas ...
FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations, and standards. Company Overview At FUJIFILM Healthcare Americas ...
FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations, and standards. Company Overview At FUJIFILM Healthcare Americas ...
FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations, and standards.Company OverviewAt FUJIFILM Healthcare Americas ...
FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations, and standards.Company OverviewAt FUJIFILM Healthcare Americas ...
GRA Device Associate - Medical Devices and Combination Products (Senior Manager)
Cambridge, MA · On-site
$122.25 - $176.58/hr
Morristown, NJ About the Job The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the medical device, combination product, digital health and in‑vitro diagnostic ...
GRA Device Associate - Medical Devices and Combination Products (Senior Manager)
Cambridge, MA · On-site
$122.25 - $176.58/hr
Morristown, NJ About the Job The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the medical device, combination product, digital health and in‑vitro diagnostic ...
Medical Device & Regulations~EIS : Testing|Inspection And Fault Finding Experience Required: 0-2
Quick apply
Medical Device & Regulations~EIS : Testing|Inspection And Fault Finding Experience Required: 0-2
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 ...
Quick apply
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 ...
Mechanical Design Engineer - NPD (Medical Device)
Irvine, CA · On-site
$81K - $110K/yr
The ideal candidate will have strong experience in New Product Development, electro-mechanical design, automation, CAD, and medical device regulatory requirements. Key Responsibilities Design and ...
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Mechanical Design Engineer - NPD (Medical Device)
Irvine, CA · On-site
$81K - $110K/yr
The ideal candidate will have strong experience in New Product Development, electro-mechanical design, automation, CAD, and medical device regulatory requirements. Key Responsibilities Design and ...
Labelling Senior Project Manager (Medical Device & Regulatory Compliance) - Fulltime
Aliso Viejo, CA · On-site
Deep knowledge of medical device regulations, supply chain operations, and change control processes. * Strong leadership, communication, and stakeholder engagement skills. * Experience with global ...
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Labelling Senior Project Manager (Medical Device & Regulatory Compliance) - Fulltime
Aliso Viejo, CA · On-site
Deep knowledge of medical device regulations, supply chain operations, and change control processes. * Strong leadership, communication, and stakeholder engagement skills. * Experience with global ...
Regulatory Device Specialist
Johnson City, TN · On-site
$65K - $73K/yr
Preferred Experience: * Minimum of 3 years Medical Device Regulatory Experience required ... aesthetics experience preferred * Solid understanding of cGMP for Medical Devices, ISO 13485, FDA ...
Regulatory Device Specialist
Johnson City, TN · On-site
$65K - $73K/yr
Preferred Experience: * Minimum of 3 years Medical Device Regulatory Experience required ... aesthetics experience preferred * Solid understanding of cGMP for Medical Devices, ISO 13485, FDA ...
Regulatory Device Specialist
Johnson City, TN · Remote
$65K - $73K/yr
Preferred Experience: * Minimum of 3 years Medical Device Regulatory Experience required ... aesthetics experience preferred * Solid understanding of cGMP for Medical Devices, ISO 13485, FDA ...
Regulatory Device Specialist
Johnson City, TN · Remote
$65K - $73K/yr
Preferred Experience: * Minimum of 3 years Medical Device Regulatory Experience required ... aesthetics experience preferred * Solid understanding of cGMP for Medical Devices, ISO 13485, FDA ...
This non-exempt position focuses on regulatory change assessments, medical device submissions, and participation in regulatory strategy and continuous improvement activities. The role serves as a ...
Quick apply
This non-exempt position focuses on regulatory change assessments, medical device submissions, and participation in regulatory strategy and continuous improvement activities. The role serves as a ...
Our team of medical device specialists, neuroscientists, and consumer electronics engineers is ... This role will help ensure regulatory strategies and deliverables are executed accurately ...
Our team of medical device specialists, neuroscientists, and consumer electronics engineers is ... This role will help ensure regulatory strategies and deliverables are executed accurately ...
Medical Device Complaint Specialist
Moundsview, MN · On-site
$24 - $27/hr
Prepare regulatory documentation and reports Core Duties * Complaint handling & investigation * Medical Device Reporting (MDR) * Adverse event processing * Regulatory compliance support * Safety data ...
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Medical Device Complaint Specialist
Moundsview, MN · On-site
$24 - $27/hr
Prepare regulatory documentation and reports Core Duties * Complaint handling & investigation * Medical Device Reporting (MDR) * Adverse event processing * Regulatory compliance support * Safety data ...
Our team of medical device specialists, neuroscientists, and consumer electronics engineers is ... This role will help ensure regulatory strategies and deliverables are executed accurately ...
Our team of medical device specialists, neuroscientists, and consumer electronics engineers is ... This role will help ensure regulatory strategies and deliverables are executed accurately ...
Senior Regulatory Specialist
Alameda, CA · On-site
Must have 7 years of experiences in Medical Device Regulatory Affairs * Considered as highly experienced with regulatory change assessments. * Working knowledge in US Medical Device Submissions
New
Senior Regulatory Specialist
Alameda, CA · On-site
Must have 7 years of experiences in Medical Device Regulatory Affairs * Considered as highly experienced with regulatory change assessments. * Working knowledge in US Medical Device Submissions
New
Director, Medical Device Interface, Regulatory Affairs
Raritan, NJ · On-site
$153K - $202K/yr
Learn more at We are searching for the best talent for Director, Medical Device Interface, Regulatory Affairs. Please note that this role is available across multiple countries and may be posted ...
Director, Medical Device Interface, Regulatory Affairs
Raritan, NJ · On-site
$153K - $202K/yr
Learn more at We are searching for the best talent for Director, Medical Device Interface, Regulatory Affairs. Please note that this role is available across multiple countries and may be posted ...
Director, Medical Device Interface, Regulatory Affairs
Raritan, NJ · On-site
$153K - $202K/yr
Learn more at We are searching for the best talent for Director, Medical Device Interface, Regulatory Affairs. Please note that this role is available across multiple countries and may be posted ...
Director, Medical Device Interface, Regulatory Affairs
Raritan, NJ · On-site
$153K - $202K/yr
Learn more at We are searching for the best talent for Director, Medical Device Interface, Regulatory Affairs. Please note that this role is available across multiple countries and may be posted ...
Director, Medical Device Interface, Regulatory Affairs
Raritan, NJ · On-site
$164 - $283/hr
Learn more at We are searching for the best talent for Director, Medical Device Interface, Regulatory Affairs. Please note that this role is available across multiple countries and may be posted ...
Director, Medical Device Interface, Regulatory Affairs
Raritan, NJ · On-site
$164 - $283/hr
Learn more at We are searching for the best talent for Director, Medical Device Interface, Regulatory Affairs. Please note that this role is available across multiple countries and may be posted ...
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 ...
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 ...
Medical Device Regulatory information
See salary details
$18.99 - $22.95
3% of jobs
$22.95 - $26.90
6% of jobs
$26.90 - $30.86
13% of jobs
$31.38 is the 25th percentile. Wages below this are outliers.
$30.86 - $34.81
20% of jobs
The median wage is $36.35 / hr.
$34.81 - $38.77
19% of jobs
$38.77 - $42.72
9% of jobs
$44.70 is the 75th percentile. Wages above this are outliers.
$42.72 - $46.68
10% of jobs
$46.68 - $50.63
6% of jobs
$50.63 - $54.59
5% of jobs
$54.59 - $58.54
5% of jobs
$58.54 - $62.50
3% of jobs
$18
$39
$62
How much do medical device regulatory jobs pay per hour?
What is a medical device regulatory professional?
What are the key skills and qualifications needed to thrive as a medical device regulatory specialist?
What are some common challenges faced by professionals in medical device regulatory roles, and how can they be addressed?
What is the difference between Medical Device Regulatory vs Medical Device Quality Assurance?
| Aspect | Medical Device Regulatory | Medical Device Quality Assurance |
|---|---|---|
| Certifications | Regulatory Affairs Certification (RAC), ISO 13485 Lead Auditor | ISO 13485 Lead Auditor, CQE |
| Work Environment | Regulatory agencies, compliance departments, documentation review | Manufacturing sites, quality control labs, audit environments |
| Employer & Industry Usage | Medical device companies, regulatory consulting firms | Manufacturers, 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.
How to get into medical device regulatory affairs?
Is medical device regulatory affairs a good career?
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:
- Remote Medical Device Sales Spine
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Medical Device Regulatory Specialist
Washington, DC • On-site
8.8
Based on 103 frontline employees who took The Breakroom Quiz
49th of 246 rated software companies
Free food
Great coworkers
People enjoy working here
Good employer
Recommended by students
Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Re-posted 18 days ago
Job description
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 - $208000 (USD) 15% bonus target 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.
About Google
Sourced by ZipRecruiter
Industry
Software development and technology, communication and media
Company size
10,000+ Employees
Headquarters location
Mountain View, CA, US