Senior Regulatory Affairs Specialist

Who We Are

Verily is a subsidiary of Alphabet that is using a data-driven approach to change the way people manage their health and the way healthcare is delivered. Launched from Google X in 2015, Our purpose is to bring the promise of precision health to everyone, every day. We are focused on generating and activating data from a variety of sources, including clinical, social, behavioral and the real world, to arrive at the best solutions for a person based on a comprehensive view of the evidence. Our unique expertise and capabilities in technology, data science and healthcare enable the entire healthcare ecosystem to drive better health outcomes.

Description

As a Senior Regulatory Affairs Specialist at Verily, you will work directly with other Regulatory Affairs team members, partners and a team of experts from diverse fields (e.g., Biology, Chemistry, Physics, Electrical Engineering, Computer Science) to develop, manage and execute regulatory strategies to obtain market clearances for innovative products.

You work with internal and external customers to support complex, multidisciplinary projects throughout the entire project lifecycle, support the development and maintenance of processes and act as a liaison between teams to ensure that quality medical products are designed, developed and marketed in a timely manner.

Responsibilities

• Provide regulatory strategic leadership on early-, mid- and late-stage medical device products; clinical validation, design and analysis for stand-alone and clinical performance; AI/ML-enabled devices versus deep learning-based systems, and SaMD products for domestic and international markets.
• Advise and direct RA submission clinical strategies for early to mid-phase products, lead regulatory submissions and/or technical files for in vitro diagnostics and medical devices supporting digital health products.
• Lead regulatory submission teams, including coordinating and leading clinical support team for successful clinical validations, guiding xFn Teams on regulatory decision-making and leading negotiating strategies with regulators.
• Lead regulatory training programs for Verily staff on applicable topics, such as FDA guidance, ISO 13485 standards and regionally-required licensing, certifications and/or registrations, GMP product development life cycle, regulatory submissions, listings, and/or registrations (US and internationally); clinical validations, clinical performance assessments, risk-benefit analysis, risk management, post-market reporting, advisory notices, field actions, and recalls; and review of labeling, marketing and promotional materials.
• Review device labeling and promotional/advertising materials for compliance with applicable regulations.

Qualifications

Minimum qualifications:

• Bachelor’s degree in a technical or scientific field (e.g., Biochemistry, Biomedical, Medical Device Software, Software/Hardware, Chemical Engineering, Regulatory Affairs or related discipline).
• 10 years of Regulatory Affairs submissions experience in medical devices, SaMDs, AI/ML-enabled medical devices, deep learning-enabled devices, and digital health software.
• Experience with FDA 21 CFR Parts 801, 803, 807, 812, 820; FDA Submissions: 510(k), PMA, DDT COA, IDE, IRB, ISO 13485:2016 MDD/MDR, CE Marking and Class I/II/III medical devices.
• Technical proficiency in at least two of the product categories described above and ability to discuss, understand and make regulatory recommendations on a wide array of medical device engineering disciplines and complex technical/logistical issues is preferred.
• Strong writing, editing and analytical skills, and have experience in developing complex submissions with minimal supervision.

Preferred qualifications:

• Experience with SaMD, Digital Biomarkers, Molecular Diagnostics, Pathology, CADe/CADx and/or Diagnostic Imaging Devices.
• Advanced degree (e.g MS, PhD, JD) or regulatory certifications (e.g. RAPS, RAC, etc.) preferred.
• 4 years experience managing or leading regulatory submissions and/or international registrations, including CE Technical File.
• Technical proficiency in at least one of the product categories described above and ability to discuss, understand and make regulatory recommendations on a wide array of medical device engineering disciplines and complex technical/logistical issues is preferred.
• Experience working with interdisciplinary, cross-functional teams in a fast-paced environment.

The US base salary range for this full-time position is $116,000-$179,000 + bonus + equity + benefits. Our salary ranges are determined by role, level, and location. The range displayed