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Facebook Regulatory Affairs Lead in Helena, Montana

Intro:

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.

Summary:

Health Technologies at Facebook is seeking a leader to develop and execute regional and global regulatory strategies for Health Technology projects aimed at improving morbidity, mortality, cost, and inequity in health outcomes. The ideal candidate will have a strong focus on digital health and will be a key leadership input to designing and executing clinical research and regulatory needs with cross functional teams and external partners.

Required Skills:

  1. Be the single threaded owner for all regulatory needs related to health technology research

  2. Help define and drive regulatory strategy for new product development, with the goal of commercializing new health technologies

  3. Demonstrate the ability to develop a variety of solutions to regulatory challenges

  4. Exercise independent judgement in setting and communicating appropriate regulatory action and requirements

  5. Be the single threaded owner for communication with regulatory agencies for product filings, clearances and strategies

Minimum Qualifications:

  1. Masters degree in science related field, or equivalent experience

  2. 10+ years of device approval experience in a regulatory affairs role, with at least 5+ years as a principal, manager or lead

  3. Experience with software as a medical device (SaMD) development, managing audits from regulatory authorities, and taking submissions through regulatory approvals

  4. Direct experience in leading interactions with US regulatory health authorities

  5. Knowledge of global regulatory health authorities

Preferred Qualifications:

  1. Experience working at the FDA and/or experience with digital health technologies

  2. Experience conducting Pre-Submission or Q-Submission program at FDA

Industry: Internet

Equal Opportunity: 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.

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