Regulatory Program Director

Proclinical is currently recruiting for a Regulatory Program Director with a leading medical technology company located in South San Francisco, CA. Successful candidate will develop and execute regional or global regulatory strategies and initiatives for assigned projects, with a strong focus on digital endpoints/digital biomarkers and software as a medical device (SaMD).

Job Responsibilities:

• Serve as primary PDR representative on one or more regional or global projects
• Provide regulatory expertise and leadership to site, regional or global cross-functional teams and other groups.
• Develop, implement, and deliver the cross-functional regulatory strategy for each project or related assignment.
• Manage decision-making surrounding regulatory issues within cross-functional teams, including coordination between other business teams and RAFT team.
• Develop regulatory risk management and contingency plans
• Act as principal interface with primary reviewers from health authorities and for other interactions with relevant regulatory-related external parties; manage the strategies for and execution of these interactions.
• Contribute to recruitment activities and on-boarding new staff members.

Skills and Requirements:

• University degree and 10+ years of relevant experience in regulatory affairs or related functions in drug and / or Software as Medical Device development.
• Broad understanding of international regulations, processes and issues in drug/biologics/ digital health, Software as Medical Device development.
• Practical experience of successfully dealing with Health Authority interactions.
• Strong cross-functional teaming skills: Has consistently excelled in cross-functional teams and regularly demonstrated collaborative and inclusive leadership.
• Strategic and Creative Thinking: Applies regulatory and scientific knowledge to elaborate solutions and solve complex problems.
• Good communication and negotiation skills.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Lewis Rooney at (+1) 415-481-3817 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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