Senior Regulatory Affairs Specialist

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 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, 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: Class I/II/III medical devices, 510(k), PMA, DDT-CoA, IDE, IRB, ISO 13485:2016, MDD/MDR CE Marking).
• 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, 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 registrations.
• 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 - $166,000 + bonus + equity + benefits. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus or benefits.

 

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