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Director Regulatory Affairs

Job LocationCambridge
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Job Title: Director of Regulatory Affairs - Medical DevicesLocation: CambridgeshireOverview:A leading innovator in the field of medical devices, committed to enhancing the lives of patients globally. They are currently seeking a highly skilled Director of Regulatory Affairs to join their Cambridgeshire team. The Director of Regulatory Affairs willbe responsible for ensuring their range of Medical Device products continue to meet regulatory requirements.Director of Regulatory Affairs - Key Responsibilities:

  • Develop and execute comprehensive regulatory strategies to ensure compliance with relevant regulations and standards; ISO 13485, IEC 60601 and IEC 62304.
  • Keep abreast of evolving global regulatory requirements and communicate their impact on the companys products and strategies.
  • Oversee the preparation and submission of regulatory applications
  • Manage interactions with regulatory agencies and notified bodies, ensuring successful approvals and clearances.
  • Develop and maintain processes for post-market surveillance, adverse event reporting, and product recalls.
  • Implement strategies for product lifecycle management, including updates, renewals, and discontinuations.
Director of Regulatory Affairs - Qualifications:
  • 7+ years of medical device regulatory experience.

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