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.

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

• 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