Medical Devices, Regulatory Affairs Specialist

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. Jobs Medical Devices, Regulatory Affairs Specialist Medical Devices, Regulatory Affairs Specialist Redmond, WA +2 locations Engineering +3 more 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. Medical Devices, Regulatory Affairs Specialist 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 globe Ensure products are brought to market on time, and sustained throughout life cycle via compliant, novel regulatory strategies Collaborate 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 products Lead 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 business Drive improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System Review and approve marketing, advertising, promotional items and labeling for regulatory compliance Minimum Qualifications Bachelor's Degree in Engineering or other Technical Science field 5+ 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) products Proven communication skills. Experience presenting clearly and persuasively to technical and non-technical audience in an environment that is not medical device native Demonstrated success in authoring technical reports, business correspondence, regulatory applications, and standard operating procedures Preferred Qualifications Master's Degree in Regulatory Affairs Regulatory Affairs Professionals Society Regulatory Affairs Certification Certification Experience with direct to consumer health wearables product both regulated and wellness Technical expertise in software development practices and how to communicate with SW engineers to get required regulatory deliverables Demonstrated ability to integrate AI tools to optimizeredesign workflows and drive measurable impact (e.g., efficiency gains, quality improvements) Experience adhering to and implementing responsible, ethical AI practices (e.g., risk assessment, bias mitigation, quality and accuracy reviews) Demonstrated ongoing AI skill development (e.g., promptcontext engineering, agent orchestration) and staying current with emerging AI technologies Meta builds technologies that help people connect, find communities, and grow businesses. When Facebook launched in 2004, it changed the way people connect. Apps like Messenger, Instagram and WhatsApp further empowered billions around the world. Now, Meta is moving beyond 2D screens toward immersive experiences like augmented and virtual reality to help build the next evolution in social technology. People who choose to build their careers by building with us at Meta help shape a future that will take us beyond what digital connection makes possible today—beyond the constraints of screens, the limits of distance, and even the rules of physics. For those who live in or expect to work from California if hired for this position, please click for additional information. $118,000year to $173,000year + bonus + equity + benefits Individual compensation is determined by skills, qualifications, experience, and location. Compensation details listed in this posting reflect the base hourly rate, monthly rate, or annual salary only, and do not include bonus, equity or sales incentives, if applicable. In addition to base compensation, Meta offers benefits. Learn more about at Meta. Equal Employment Opportunity Meta is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, reproductive health decisions, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetic information, political views or activity, or other applicable legally protected characteristics. You may view our Equal Employment Opportunity notice . Meta is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, fill out the Accommodations request form .