**Summary:** Reality Labs Wearables are growing and showing what the combination of AI with great form factors can do. We are seeking an experienced medical devices regulatory affairs professional to help us execute regulatory strategy and product approvals for novel hardware and software as a medical device products with distribution into many worldwide markets. **Required Skills:** Medical Devices Regulatory Affairs Strategy Specialist Responsibilities: 1. 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 2. Ensure products are brought to market on time, and sustained throughout life cycle via compliant and innovative regulatory strategies 3. 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 4. 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 5. Drive improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System 6. Review and approve marketing, advertising, promotional items and labeling for regulatory compliance **Minimum Qualifications:** Minimum Qualifications: 7. Bachelor’s Degree in Biomedical Engineering or other Technical Science field or equivalent work experience 8. 5+ years of work experience in a highly regulated industry as a regulatory affairs professional (e.g., Medical Devices, Bioengineering, Pharma, Life Sciences) 9. Knowledge and experience in the application of the Medical Device Directive & European Union Medical Device Regulation, FDA regulatory approval pathways DeNovo and 510k, and other worldwide regulators in particular for Software as a Medical Device (SaMD) products 10. Experience authoreing technical reports, business correspondence and standard operating procedures that are clear and actionable 11. Communication skills. Experience presenting to technical and non-technical audience **Preferred Qualifications:** Preferred Qualifications: 12. Direct experience with consumer wearables and software as a medical device applications 13. Master’s Degree in Regulatory Affairs 14. Regulatory Affairs Professionals Society Regulatory Affairs Certification **Public Compensation:** $116,000/year to $168,000/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. Please note that 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 accommodations-ext@fb.com.