Manager - Regulatory Affairs, Europe

April 27

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MCRA

Clinical Affairs • Quality Assurance • Regulatory Affairs • Reimbursement • Healthcare Compliance

51 - 200 employees

Description

• MCRA is seeking a Manager, Regulatory Affairs- Europe who will be a remote-based employee located in the UK or Germany with expertise in EU MDR and UK MDR. • Responsibilities include writing, reviewing, and managing regulatory submissions, development of overall regulatory strategy, and communicating with regulatory bodies and clients with support of senior MCRA staff.

Requirements

• Bachelor’s degree in a scientific, engineering, or regulatory discipline; MS or PhD preferred. • Minimum five years of experience in Regulatory Affairs related to medical devices, drugs and/or biologics, developing regulatory deliverables and submissions.

Benefits

• Complete other duties and projects as assigned. • Attend conferences and meetings as needed.

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