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Job Information

Quality & Regulatory Affairs Manager

Information About this Role

Job description

Job Title: Quality & Regulatory Affairs Manager

Location: London, United Kingdom

Industry: Medical Devices

Salary: Contract or Permanent with Competitive salary and great benefits!

Overview:

  • Responsible for aligning the company’s business needs to regulatory and legislative change.
  • Manage and lead QA&RA staff.
  • Managing policy strategy and regulatory requirements.
  • Make sure regulatory compliance is achieved.

As a Quality & Regulatory Affairs Manager you will be responsible for:

  • Review and maintain the company quality management system ensuring quality documentation, processes and procedures and compliance to regulatory requirements.
  • Managing international product submissions.
  • Determine reportable events / incidents and advice the managing director accordingly.
  • Manage CAPA system, ensuring system is fully compliant to regulations and fully utilised to ensure product non-conformance is reduced and quality system is improved.

To apply for the role of Quality & Regulatory Affairs Manager you will have:

  • A proven track record / credentials in Regulatory Affairs management. (i.e. FDA, TGA) and ISO 13485.
  • Medical device QA & RA experience.
  • Must have experience of dealing with process validation, sterilisation, reprocessing surgical instruments.
  • Must have excellent I.T. skills to maintain various databases and present quality data in the form of departmental reports.
  • Previous Medical Device experience.
  • A valid UK driving licence.

If you are curious about this exciting opportunity as a Quality & Regulatory Affairs Manager APPLY NOW and change your life today.

For more information about the role call me Matthew for a confidential chat on 0203 8000 516 or email me on today.

Due to a high number of applicants, only successful candidates will be contacted. A consultant will reach you within 7 working days.