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Senior Regulatory Affairs Specialist - South San Francisco, United States - Verily
Description
Who We AreVerily 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 and 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.
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.
Why Join Us
Build What's Vital.
At Verily, you are a part of something bigger.
We are a diverse team of builders innovating at the intersection of health and technology-united by a shared spirit of curiosity, resilience and determination to make better health possible for all.
This builder mindset means your fingerprints will be on the work that shapes the future of health.
Fulfilling our precision health purpose starts with the health of our Veeps, which is why we offer flexibility, resources, and competitive benefits to support you in your whole-person well being.
Our culture reflects the behaviors that stem from living our values every day in how we Innovate Healthcare and Technology, Gain Velocity as One Verily, and Respect Individuals.
As One Verily, we uphold our collective accountability to sustain this culture and to create a VIBE (Verily's Culture of Inclusion, Belonging, and Equitability) where all Veeps feel included, a sense of belonging, and have opportunities to grow.
If this sounds exciting to you, we would love to hear from you.You can find out more about our company culture on our LinkedIn Company Page and Verily Careers page .
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