Regulatory Affairs Specialist for Medical Devices

Summary: Join our innovative team as a Regulatory Affairs Specialist dedicated to shaping the future of medical devices! We are looking for a skilled professional to navigate the complex landscape of regulatory strategies and manage product submissions for groundbreaking hardware and software as a medical device (SaMD) products aimed at global markets. Leverage your expertise to collaborate with diverse teams and facilitate the successful launch of cutting-edge medical devices within our growing portfolio, which includes wearables and artificial intelligence (AI) products. Key Responsibilities: Act as a principal team member providing comprehensive Regulatory Affairs insights for new product launches and modifications worldwide. Develop and execute innovative regulatory strategies to ensure timely product market entry and compliance throughout the product life cycle. Build and maintain strategic partnerships with external stakeholders such as Notified Bodies, FDA, Competent Authorities, and other regulatory entities to ensure clarity on requirements during strategy formulation. Foster collaboration among cross-functional teams, including Legal, Engineering, Product Management, Quality Compliance, and Clinical Affairs, to drive regulatory success at all organizational levels. Enhance the regulatory components of the Quality System by developing robust processes and documentation for effective management. Review and approve marketing materials, advertisements, and labeling to ensure they meet regulatory standards. Minimum Qualifications: Bachelor's Degree in Engineering or a related Technical Science field. 5+ years of experience in a regulated industry as a regulatory affairs professional, such as Medical Devices, Bioengineering, Pharma, or Life Sciences. Proven track record with MDD & EU MDR, FDA approval pathways (DeNovo and 510k), and global regulations, particularly for SaMD products. Strong communication skills, capable of presenting effectively to technical and non-technical audiences in a non-medical device-focused environment. Experience in authoring technical reports, regulatory applications, standard operating procedures, and business correspondence. Preferred Qualifications: Master's Degree in Regulatory Affairs. Certification from the Regulatory Affairs Professionals Society. Experience with direct-to-consumer health wearables, including both regulated and wellness products. Technical proficiency in software development practices and the ability to communicate effectively with software engineers regarding regulatory deliverables. Compensation: $118,000/year to $173,000/year plus bonus, equity, and comprehensive benefits. Meta is an Equal Employment Opportunity and Affirmative Action employer. We embrace diversity and do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, disability, or other legally protected characteristics. We welcome qualified applicants with criminal histories consistent with the law. We are committed to reasonable accommodations for candidates with disabilities throughout the hiring process.

Created: 2026-03-04