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Quality and Regulatory Coordinator

Reference Number: 924821 | Location: East Sussex, United Kingdom | Division: Scientific Permanent

Quality and Regulatory Coordinator

East Sussex


Medical Devices

The role

This is an amazing opportunity to join a growing medical device company based in East Sussex designing and supplying healthcare products. You will ensure continued compliance of the Quality Management System Documentation including records to harmonized standards and regulatory requirements. Working closely alongside the quality manager, any gaps in your knowledge and experience will be quickly filled and you will have the opportunity to grow into the Quality Manager position when the opportunity arises

The company

My client is fast growing and designs and supplies disposable healthcare products and provides innovative solutions to resolving patient problems.

Duties and Responsibilities for the Position

  • Maintains the Quality Management System
  • Provides training to company employees on the Quality Management System in accordance to the organisations policies
  • Liaise with regulatory authorities (certification bodies, AO/notified bodies and/or competent authorities) as and when required.
  • Booking and managing corrective and preventive actions (CAPAs) and lead CAPA teams when and where necessary.
  • Manage customer complaints and lead internal investigations.
  • Co-ordinate, support and manage all on-site audits conducted by external bodies (customer and/or other regulatory authorities) ensuring all findings are captured, followed up and closed out in a timely manner through CAPA process
  • Conduct, manage and coordinate all internal audits (internal audits and technical file audits) in accordance to the schedule
  • Conduct, coordinate and manage management review and production meetings
  • Work closely with purchasing to establish supplier evaluation, quality performance criteria and monitor periodic supplier performance
  • Conduct final QC checks and release of completed product
  • Manage the non-conforming products process
  • Other duties as deemed necessary

Knowledge, Skills and Ability

  • It is important that you are willing to give long term commitment to the organisation and have a strong desire to learn and progress with the team.
  • You must be able to work under pressure and should be self-motivated to use time productively.

The below are preferred but not essential as training will be given

  • Knowledge of various management systems in medical device industry and international standards like ISO9001, ISO13485, and ISO14644.
  • Knowledge of the EU, UK, USA, Canada and ROW regulations (Medical Device Directive 93/42/EEC, 21 CFR Part 820 and SOR 98-282)
  • Knowledge and experience of creating and maintaining CE technical files
  • Trained as an internal auditor against ISO 19011 for either ISO 9001 or ISO13485
  • Experience in maintaining and managing CAPA and Complaints Handling

Harris Lord is acting as a recruitment agency for this role.

Contact: Adrian Hole

Keywords: QMS, Quality, Quality Management System, 13485, medical device, regulations, regulatory, audit, CAPA, change control, deviation, notified body

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