Medical Devices Regulatory Affairs Strategy Specialist

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.Medical Devices Regulatory Affairs Strategy 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 and 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 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 Biomedical Engineering or other Technical Science field or equivalent work experience
• 5+ years of work experience in a highly regulated industry as a regulatory affairs professional (e.g., Medical Devices, Bioengineering, Pharma, Life Sciences)
• 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
• Experience authoreing technical reports, business correspondence and standard operating procedures that are clear and actionable
• Communication skills. Experience presenting to technical and non-technical audience

Preferred Qualifications

• Direct experience with consumer wearables and software as a medical device applications
• Master’s Degree in Regulatory Affairs
• Regulatory Affairs Professionals Society Regulatory Affairs Certification

For those who live in or expect to work from California if hired for this position, please click here for additional information. 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.
$116,000/year to $168,000/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.

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