Senior Regulatory Affairs Specialist, Digital Health

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 closely with other Regulatory Affairs team members, 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 will work with internal and external customers to support complex, multidisciplinary projects throughout the entire product lifecycle. You will provide regulatory requirements and guidance in support of the development and maintenance of products and processes. You will act as a liaison to and partner with teams to ensure that high quality medical device/digital health products are designed, developed and marketed in a timely manner.

Responsibilities

• Provide regulatory strategic leadership and guidance on medical device/digital health projects throughout the product development lifecycle, including clinical validation, analysis for stand-alone and clinical performance; AI/ML-enabled devices and SaMD products for domestic and international markets.

• Lead, manage and prepare regulatory submissions and/or technical files for medical devices and in vitro diagnostics. Engage with, negotiate and manage relationships with regulatory authorities.

• Develop and improve on regulatory procedures and work instructions as necessary. Address audit findings as appropriate. Monitor and share info on the evolving regulatory environment/landscape. Interpret new regulations for cross-functional team understanding.

• Review device labeling and promotional/advertising materials for compliance with applicable regulations.

• Lead regulatory training programs for Verily staff on applicable topics, such as FDA guidance, ISO 13485 standards, regulatory submissions, listings, and/or registrations (US and internationally); and post market surveillance activities.

Qualifications

Minimum Qualifications

• Bachelor's degree in a technical or scientific field (e.g. Biochemistry, Biomedical, Digital Biomarkers, Medical Device Software, Software/Hardware, Chemical Engineering, Regulatory Affairs, or related discipline).

• 7+ 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 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.

• Strong communication, writing, editing and analytical skills. Have experience in developing complex submissions. Strong organization and attention to detail. Ability to manage multiple programs/tasks. Work independently and cross-functionally with minimal supervision.

Preferred Qualifications

• Experience with SaMD, Digital Biomarkers, CADe/CADx and/or Diagnostic Imaging Devices.

• Experience working with interdisciplinary, cross-functional teams in a fast-paced environment.

• Advanced degree (e.g MS, PhD, JD) or regulatory certifications (e.g. RAPS, RAC, etc.).

• 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.

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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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.