Medical Devices, Regulatory Affairs Specialist
Job in
Redmond, King County, Washington, 98052, USA
Listing for:
Meta
Full Time
position
Listed on 2026-03-01
Job specializations:
-
Healthcare
Healthcare Management
Salary/Wage Range or Industry Benchmark: 118000 - 173000 USD Yearly
USD
118000.00
173000.00
YEAR
Job Description & How to Apply Below
Overview
We are seeking an experienced medical devices regulatory affairs professional to develop and execute regulatory strategies and manage product submissions for novel hardware and software as a medical device (SaMD) products for distribution into worldwide markets. You will apply your subject matter expertise in regulatory strategy and approvals to partner with cross-functional teams, enabling the launch of regulated medical devices. This role is within an organization primarily focused on consumer electronics but with an expanding medical device portfolio in wearables and artificial intelligence (AI) products.
Responsibilities
Act as the core team member for end-to-end Regulatory Affairs input and deliverables for new product introductions and product changes across the globeEnsure products are brought to market on time, and sustained throughout life cycle via compliant, novel regulatory strategiesCollaborate proactively and establish strategic relationships with external stakeholders (Notified Bodies, FDA, Competent Authorities and other regulatory bodies) to ensure that requirements are known early during strategy development, enabling rapid market access to Meta Reality Labs productsLead and enable cross-functional partnerships between Regulatory Affairs and all key stakeholders including Legal, Engineering, Product Management, Quality Compliance, Clinical Affairs and other functions at all levels within the businessDrive improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality SystemReview and approve marketing, advertising, promotional items and labeling for regulatory complianceMinimum Qualifications
Bachelor’s Degree in Engineering or other Technical Science field5+ years of work experience in a highly regulated industry as a regulatory affairs professional (e.g., Medical Devices, Bioengineering, Pharma, Life Sciences)Demonstrated success in the application of the MDD & EU MDR, FDA regulatory approval pathways DeNovo and 510k, and other worldwide regulators in particular for Software as a Medical Device (SaMD) productsProven communication skills. Experience presenting clearly and persuasively to technical and non-technical audience in an environment that is not medical device nativeDemonstrated success in authoring technical reports, business correspondence, regulatory applications, and standard operating proceduresPreferred Qualifications
Master’s Degree in Regulatory AffairsRegulatory Affairs Professionals Society Regulatory Affairs Certification CertificationExperience with direct to consumer health wearables product both regulated and wellnessTechnical expertise in software development practices and how to communicate with SW engineers to get required regulatory deliverablesCompensation and Industry
Public Compensation: $118,000/year to $173,000/year + bonus + equity + benefits
Industry: Internet
Equal Opportunity
Meta is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender, gender identity, gender expression, transgender status, sexual stereotypes, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
We also consider qualified applicants with criminal histories, consistent with applicable federal, state and local law. Meta participates in the E-Verify program in certain locations, as required by law. Meta may leverage artificial intelligence and machine learning technologies in connection with applications for employment.
Meta is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know at
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