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General** **Description:

The Regulatory Affairs Director Dx/CDx and Medical Devices will be responsible for leading a small team for developing and implementing regulatory diagnostic and medical device strategies, for the designated program(s) to support clinical trials where necessary, and facilitate marketing authorization in line with business objectives, and in coordination with key internal and external stakeholders.

Essential** **Functions** **of** **the** **job:

+ Develop US regulatory strategy for the designated program(s) and contribute to the clinical development plans to align diagnostic testing and drive integration to therapeutic development plans.

+ Act as the representative of the US regulatory team at the global regulatory team (GRT) for the designated projects needing diagnostics, and may also be required to represent diagnostic strategies to global cross-functional teams on specific programs or for specific topics

+ Drive the strategy, providing direction and oversight for Dx/CDx and Device related content of regulatory documents, such as assessments, regulatory memos, and briefing documents and responses, for interactions with US regulatory authorities, as applicable.

+ Provide submission gap analyses, identify potential risks and propose potential solutions/mitigation plans to ensure successful acceptance of diagnostic submissions

+ Oversee and be accountable for Dx/CDx and Device related regulatory agency communications, submissions, and approvals, with a quality focus to minimize cyclical review

+ Lead and mentor team members

+ Maintain up-to-date working knowledge of laws, regulations, and guidelines applicable to the US testing space.

+ Represent BeOne’s US Dx/CDx and MedDev regulatory function at industry consortium (may be required).

Other** **Qualifications:

+ Minimum BS with 10+ years, MS with 7+ years or PhD/MD/PharmD with 5+ years of experience in the biotechnical or pharmaceutical industry, and 5+ years of experience in a Regulatory capacity with broad and in-depth regulatory knowledge and substantial working experience, or 10+ years of experience in the biotechnical or pharmaceutical industry, and a minimum of 5 years’ experience in a Regulatory capacity with increasing responsibility.

+ Seasoned negotiator, both internally and externally with a solid background in medical devices/diagnostic development regulations and associated regulatory deliverables.

+ Experience working with various Health Authorities, primarily FDA, to support diagnostic testing.

+ Sound understanding of the drug and diagnostic development process, the pharmaceutical industry and healthcare environment including Global and US regulatory requirements and policy trends

+ Recent experience with diagnostic testing to support clinical trials in all phases of study, is mandatory for this role.

+ Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism

+ English native speaker is preferred

+ **Location:** US (remote).

**Reports To:** Executive Director, Global Regulatory Strategy, Dx/CDx and Medical Devices.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.