Senior Regulatory Affairs Specialist, Medical Devices

September 26

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Description

• Verily is a subsidiary of Alphabet using a data-driven approach to health management. • Work with Regulatory Affairs team members to develop regulatory strategies for medical devices. • Support multidisciplinary projects throughout the entire project lifecycle and ensure quality medical products are marketed in a timely manner. • Provide regulatory strategic leadership on medical device products and advise on clinical strategies. • Lead regulatory submission teams and train Verily staff on FDA software and regulatory requirements. • Review device labeling and promotional materials for compliance.

Requirements

• 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). • 8+ 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. • 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.

Benefits

• Bonus • Equity • Benefits