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Job

Quality and Regulatory Lead

Quality and Regulatory Specialist

Berkshire (occasional work from home available)

£60,000 - £70,000

The role


An international medical devices manufacturer is now hiring for a quality, compliance and regulatory professional to join their growing business.

As a key member of the Regulatory Affairs team you will lead the European regulatory and compliance efforts, whilst working closely with the global regulatory team on global registration and compliance activities.

As a Quality and Regulatory specialist you will also be responsible for the maintenance of the quality management system (QMS) for European facilities, whilst identifying opportunities for improvement.

As the interface between customers, regulatory agencies, certification bodies and colleagues, this role offers a great opportunity to work with a diverse range of stakeholders worldwide!

Key responsibilities;

  • Ensure products and processes are compliant with ISO 13485, MDD/MDR, TPED, FDA et .
  • Manage and maintain the QMS for European-based facilities
  • Lead document submissions and related efforts to secure product approvals
  • Work closely with design and engineering on new product releases (design control requirements, testing, approvals, labelling and post market reporting)
  • Post market surveillance
  • Lead quality and regulated related training in European facilities
  • Assist with European Vigilance activities
  • Participate in internal and eternal audits

What's on offer?

  • £60,000-£70,000
  • Benefits package - TBC

What experience/skills are required to apply?


Essential;

  • Minimum 3 years quality and regulatory experience in the medical devices field
  • Working knowledge of ISO13485 and MDD
  • Good written and verbal communication
  • Proven ability to manage multiple tasks/projects and work with cross functional teams
  • UK driving licence

Beneficial (not essential);

  • Working knowledge of a range of quality and regulatory standards TPED, FDA, PED etc.
  • Working knowledge of international product approvals
  • Engineering or technical bachelor's degree (or higher)

What happened next?

Click APPLY NOW to being your application. Should you be suitable a CBSbutler representative will be in touch within 5 working days.