Global Regulatory Affairs Director

3 days ago


Gloucester, Gloucestershire, United Kingdom Omega Full time
Job Summary

We are currently recruiting for a Regulatory Affairs Manager to lead our team's efforts in maintaining regulatory compliance and ensuring market access for medical devices internationally.

This is an exciting opportunity for a highly motivated and experienced professional to join our dynamic team and contribute to the company's overall goal of maintaining quality standards and business compliance.

The ideal candidate will have a strong background in medical devices, quality management systems, and regulatory affairs, with excellent communication and leadership skills.

Key Responsibilities:

  1. Maintaining up-to-date knowledge of domestic and international regulatory requirements and communicating effectively with stakeholders.
  2. Supporting the maintenance of the Quality Management System in accordance with relevant regulations.
  3. Developing and preparing high-quality technical files, design dossiers, and other necessary applications for regulatory submissions and approvals.
  4. Issuing advisory notices as required, adhering to MDD, MDR, and FDA regulatory requirements.

Requirements:

  • Proven experience in regulatory affairs, preferably in a managerial position.
  • Essential medical device experience, with Lead Auditor training and MDR experience desirable.

Benefits:

  • 25 days annual leave + Bank Holidays.
  • Private Health Care Options.
  • Employee Assistance Programmes.
  • Competitive Pension Scheme.

Estimated Salary: £65,000 - £85,000 per annum, depending on experience.



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