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Head of Medical Devices Regulatory Affairs

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Head of Medical Devices Regulatory Affairs
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Sunnyvale, CA • Redmond, WA • Burlingame, CA • Seattle, WA+ 3 more
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Reality Labs is seeking an experienced medical devices regulatory affairs professional to lead the regulatory strategy and product approvals for novel hardware and software as a medical device products for distribution into many worldwide markets. The ideal candidate is a subject matter expert who can work cross functionally to drive medical devices regulatory goals in an organization that is primarily consumer electronics focused but has a growing medical device portfolio. The ideal candidate will act as the leader for the growing Medical Devices Regulatory Affairs team, be an internal consultant to other functions, and have deep domain experience in electromechanical devices and software as a medical device (SaMD).
Head of Medical Devices Regulatory Affairs Responsibilities
  • Lead project teams 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, innovative 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 strong cross-functional partnership between Regulatory Affairs and all key stakeholders including 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
  • Establish growth plans and hire excellent talent to the organization that intelligently scales with the business needs
  • Review and approve marketing, advertising, promotional items and labeling for regulatory compliance
Minimum Qualifications
  • Bachelor’s Degree in Biomedical Engineering or other Technical Science field
  • 12+ years of work experience in a highly regulated industry as a regulatory affairs professional (e.g., Medical Devices, Bioengineering, Pharma, LifeSciences)
  • Demonstrated knowledge and experience 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
  • Experience authoring technical reports, business correspondence and standard operating procedures
  • Proven communication skills. Experience presenting clearly and persuasively to technical, non-technical, and regulator audiences
  • Proven leadership qualities in developing top talent, championing new initiatives in a large organization, and representing the organization to outside regulatory agencies
Preferred Qualifications
  • Master’s Degree in Regulatory Affairs
  • RAC Certification
  • Extensive knowledge of a broad set of regulations, standards and guidance for medical devices (MDR, MEDDEV, MDCG, IMDRF, FDA QSR, SaMD, cybersecurity, ISO 13485, ISO 14971, IEC 62304, etc.)
  • Technical expertise in software development practices and how to communicate with SW engineers to get required regulatory deliverables
  • Direct to consumer health wearables product experience
  • Experience working in fast moving, high tech companies
For those who live in or expect to work from California if hired for this position, please click here for additional information.
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About Meta
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.
Meta is committed to providing reasonable support (called accommodations) in our recruiting processes for candidates with disabilities, long term conditions, mental health conditions or sincerely held religious beliefs, or who are neurodivergent or require pregnancy-related support. If you need support, please reach out to accommodations-ext@fb.com.
$204,000/year to $281,000/year + 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 benefits at Meta.
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