Regulatory Program Director - Devices and Combination Products

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.

Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society.

The Opportunity

The Regulatory Program Director is develops and implements regulatory strategies for combination products and standalone physical devices in accordance with domestic and international regulations and guidance. In addition to portfolio-related responsibilities, the individual plays a role to build regulatory capabilities, craft regulatory policy, and establish the vital device regulatory infrastructures/processes to support our portfolio.

What You'll Do

You have deep, specialist knowledge in regulatory affairs and a broad understanding of related fields. You will contribute to large or global cross-functional teams, often in a leading capacity, and may mentor colleagues to help them develop their expertise and skills. Additionally, you will adeptly navigate complex situations by applying a diverse skills.

• Serve as Device Regulatory Lead on assigned product teams, both pre-launch and post-launch.

• Develop and implement global regulatory strategies for devices, including innovative approaches for pipeline and portfolio advancement, and provide guidance to project teams.

• Lead or support health authority interactions related to devices, in collaboration with internal team members.

• Prepare and submit device regulatory packages (e.g., briefing packages, IND/CTA, BLA/NDA/MAA, CE-mark, 510(k), de novo), ensuring high quality and timely compilation.

• Identify and manage potential regulatory risks, ensuring proper communication, resolution, and escalation when necessary.

• Act as a device regulatory subject matter expert, providing internal training, mentoring junior regulatory professionals, and leading internal initiatives to establish regulatory processes and systems.

• Engage with regulatory bodies and industry groups to influence device regulatory standards, build strong internal collaborations, and stay updated on changing regulations and their impact.

Who You Are

• You have a bachelor's degree in a scientific field, an advanced degree is desired

• You have a minimum of 10 years of regulatory and/or quality related experience in the medical device and/or biopharmaceutical industries, including applicable experience with devices.

• You have demonstrated knowledge of ICH guidance documents and health authority regulations/standards relevant to devices, specifically 21 CFR part 4, 21 CFR part 820, 21 CFR part 803, IEC 62633, ISO 13485, IEC 62304, cybersecurity, mobile medical applications, digital therapeutic, clinical decision support systems, and EU Medical Device Regulation.

• You have experience in leading and securing CE-mark, 510(k), PMA, NDA, BLA, IND, CTA regulatory approvals.

• You have a dynamic personality, with the ability to think of novel solutions and take smart risks. You also have the ability to see the big picture, think at the "system level" while also focusing on the details.

• You will collaborate cross-functionally and divisionally in Roche to leverage regulatory expertise and achieve business needs in a streamlined manner.

• You are an effective problem solver with strong organizational skills including the ability to prioritize tasks and you also drive for continuous improvement and operate with a LEAN mindset

• You have the ability to travel up to 10% of the time.

Relocation benefits are not available for this role.

The expected salary range for this position based on the primary location of South San Francisco, CA is $155,600 - $289,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.