Principal Regulatory Affairs Specialist, SaMD

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 Principal 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 will 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

• Seen as RA leader throughout the organizations they support.
• Establish influence and credibility across the organization; provide input to key decision makers that have a direct impact on the future direction of the RA program.
• Drive and own strategic RA programs that are large and complex, span multiple organizations and have a direct measurable regulatory and business impact on what are often company level OKRs.
• Identify process breakdowns in the organization, navigate through ambiguity, define a RA submissions program / process to address complex problems and implement solutions that improve the organization's effectiveness.
• Consider the "bigger picture"; drive long term objectives as well as near term deliverables.

Minimum Qualifications:

• BS degree in science/engineering-related field.
• At least 10 years of work experience in an FDA regulated medical device, biotech, life sciences, healthtech or related industry.
• 8+ experience working with SaMD products or device software.
• Ability to apply strong analytical, business and communication skills, as well as technical standards, principles, theories, concepts and techniques.

Preferred Qualifications:

• Experience with SaMD, Digital Biomarkers, Molecular Diagnostics, Pathology and/or Diagnostic Imaging Devices.
• Advanced degree (e.g MS, PhD, JD) or regulatory certifications (e.g. RAPS, RAC, etc.), preferred.
• Extensive experience managing or leading regulatory submissions and/or international registrations, including CE Technical File per EU MDR.
• Experience with regulatory agencies, e.g. FDA and notified bodies.
• 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 $140,000 -200,000 + 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 .