Senior Regulatory Affairs Manager

hace 2 días


Zaragoza, Zaragoza, España Cpl Healthcare A tiempo completo

Job Title:
Senior Regulatory Affairs Manager - Medical Device/Post-

Job Summary:

Cpl Healthcare is seeking a Senior Regulatory Affairs Manager to join our team in Spain, Madrid. As a Senior Regulatory Affairs Manager, you will be responsible for the strategic lifecycle management of our medical device portfolio, including post-CE approval and operational execution management with our Regulatory Service Provider.

Main Responsibilities:

• Be the primary regulatory point of contact for all medical device queries, providing guidance on regulatory medical device requirements and compliance to brand teams and other areas of the business.

• Lead and support all post-market surveillance activities for the medical device portfolio in the UK, Europe, and growth regions.

• Drive all Regulatory Affairs Medical Device strategies for global regions.

• Oversee, manage, and advise the Regulatory Service Provider on medical device maintenance and submission strategies, plans, and preparation of updates to the technical file and regulatory submissions for all medical device-related changes.

Requirements:

• BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science or healthcare preferred or equivalent relevant experience.

• Previous experience in Regulatory Affairs is a MUST.

• At least 8 years + experience within the medical device sector with a sound understanding of new registrations and post-market surveillance activities.



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