Job Description

Facebook's mission is to give people the power to build community and bring the world closer together. Through our family of apps and services, we're building a different kind of company that connects billions of people around the world, gives them ways to share what matters most to them, and helps bring people closer together. Whether we're creating new products or helping a small business expand its reach, people at Facebook are builders at heart. Our global teams are constantly iterating, solving problems, and working together to empower people around the world to build community and connect in meaningful ways. Together, we can help people build stronger communities - we're just getting started.

The Facebook Reality Labs (FRL) team at Facebook builds the AR/VR hardware and platform to let you experience anything, anywhere, with anyone. Additionally, Facebook has teams dedicated to building social experiences in AR/VR that make it easier to spend time with your friends, wherever they are. Augmented/Virtual reality’s potential to connect the world is immense—and we’re just getting started. Our FDA Compliance team is responsible for ensuring all Consumer products being developed by FRL meet all applicable FDA Regulatory requirements including the implementation of any requirements Quality Management System (QMS). This individual should have deep regulatory knowledge, hands-on experience, and the ability to work cross functionally to implement a robust QMS that enables rapid product development and compliance throughout the product lifecycle.

Responsibilities

• Acts as Management Representative for Facebook under ISO 13485 and 21 CFR 820.20(3).
• Ensures international compliance including Canadian Medical Device Regulations, Australian (TGA) Regulations, 13485, Europe and all international market medical device requirements.
• Works with Legal and Product teams to develop a FDA compliance strategy for each product and work across teams to execute the strategy through the QMS.
• Point of contact for all regulatory communication for the company including incident reports, audits and registrations.
• Responsible for instituting a QMS working cross functionally across customer service, design, legal, supply chain and quality functions to ensure overall Facebook compliance.
• Coordinate internal audits, manage external audits, correspondence and corrective actions of all audit findings.
• Generate and manage corrective and preventative actions using the CAPA system.
• Responsible for establishing and reviewing the company Quality Objectives each year.
• Responsible for responding to and reporting all approved markets (US and international) where the company has registered products.
• Up to 20% domestic and international travel required.
  

Minimum Qualification

• BS or MS with related medical device compliance experience.
• 10+ years of experience leading a cross-functional team at a multinational company.
• 5+ years of experience with class I and class II regulated medical products.
• Experience developing and implementing a QMS.
  
  

Preferred Qualification

• Consumer health product experience.
• Successful implementation of a QMS at a traditional technology product company.
• Wearable medical device product experience.
• International medical device regulatory experience.
• Software-feature medical device compliance experience.
  

Facebook is proud to be an Equal 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. Facebook 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.