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Quality and Regulatory Manager

Reference Number: 923280 | Location: East Sussex, United Kingdom | Division: Scientific Permanent


Quality and Regulatory Manager

East Sussex

£40,000 - £50,000

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.

The company

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

Key responsibilities

  • To adhere to the Company Management System
  • Maintains the Quality Management System
  • Provides training to company employees on the Quality Management System
  • Liaise with Certification Companies, Notified Bodies and Regulatory Authorities as and when required.
  • Manage corrective and preventive actions (CAPAs) and lead CAPA teams as necessary.
  • Manage Customer Complaints and lead internal investigations into Customer Complaints.
  • Co-ordinate and support on-site audits conducted by external providers ensure all findings are followed up and closed out in a timely manner.
  • Manages the Audit process and performs Supplier Audits, Internal Audits and Technical File Audits.
  • Work closely with Purchasing to establish supplier evaluation, quality performance criteria and monitor supplier performance.
  • Other duties as deemed necessary

 

Essential skills

  • A Quality professional, educated to degree level (or equivalent), with considerable quality experience (e.g. BS EN ISO13485 & BS EN ISO9001) within a medical device related environment.
  • Knowledge of the Medical Device Directive 93/42/EEC and experience creating and maintaining CE technical files
  • Lead Auditor or trained as an internal auditor
  • Knowledge of relevant regulatory requirements
  • Experience with maintaining corrective action programs and Complaints Handling

Harris Lord is acting as a recruitment agency for this role


Contact: Adrian Hole

Keywords: 13485, medical device, audit, FDA, regulatory, technical file


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