Director Regulatory Affairs Medical Devices

Novartis Pharmaceuticals Cambridge , MA 02138

Posted 2 months ago

Job Description:
200+ projects in development. 20 major approvals. 20 major submissions. And that's just in 2018. This is your chance to help reimagine medicine in 2019. Novartis is looking for dedicated individuals to join our Global Regulatory Affairs team and contribute to developing our superlative pipeline of drugs and biologics into innovative therapies for our patients worldwide. And it all starts with you. Your interest, your talent, your initiative. Take the first step by looking at our track record of amazing accomplishments on behalf of our patients. Novartis employees have enjoyed long, rewarding careers working with colleagues around the world via flexible, family friendly arrangements. Read on for details about the role and how you can join a world-class organization at the forefront of the industry and how you can further your career.

Your responsibilities-

o Provide device/diagnostic regulatory leadership to assigned projects.

o Develop high quality and globally aligned regulatory strategies to achieve optimal development objectives and life cycle management plans.

o Initiate and lead device/diagnostic related interactions and negotiations with Health Authorities and Notified Bodies as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans.

o Lead and drive all device related global submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects, while applying the global strategy into submissions (e.g., pre-submission briefing books, 510(K), PMA, IDE, IND, CTA, IMPD, NDA, MAA, Drug/Device Master Files, , STEDs, Annual Reports, Amendments, Supplements, etc.).

o Provide input on, and review specifications, process design controls, human factors study protocols, labeling, etc. as the Medical Device Regulatory lead on Program sub teams such as a technical sub-team or a Precision Medicine sub-team for assigned programs.

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Director Regulatory Affairs Medical Devices

Novartis Pharmaceuticals