Regulatory Compliance Specialist

3 weeks ago


Gloucester, Gloucestershire, United Kingdom Omega Resource Group Full time

Regulatory Affairs Manager Job Description

About the Role

We are seeking a highly skilled Regulatory Affairs Manager to join our team at Omega Resource Group. As a key member of our team, you will be responsible for ensuring business compliance with regulatory requirements and quality standards.

Key Responsibilities

  • Ensure business compliance with regulatory requirements and quality standards.
  • Maintain up-to-date knowledge on domestic and international regulatory requirements.
  • Communicate effectively with management and project teams.
  • Support the maintenance of the Quality Management System in accordance with relevant regulatory/statutory requirements.
  • Develop and prepare technical files, design dossiers, and other necessary applications for regulatory submissions and approvals.
  • Provide advisory notices as required, in accordance with MDD, MDR, and FDA regulatory requirements.
  • Proven experience within regulatory affairs with an extensive amount being in a managerial position.
  • Medical Device experience is essential.
  • Lead Auditor training.

What We Offer

We offer a competitive package including 25 days annual leave + Bank Holidays, Private Health Care Options, Employee Assistance Programmes, and a Competitive Pension Scheme.

Requirements

Our ideal candidate will have a background in regulatory affairs with experience in a managerial position. Medical Device experience is essential. Lead Auditor training is also required.



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