Overview

Reference Number: JO-2109-476024
Quality and Regulatory Manager
Rate: Negotiable
Job Type: Permanent
Location: Cambridge

Our client is a specialist in quality scientific instruments within Clinical and life science applications. They have an exiting opening for a Quality and regulatory manager to join them.

Duties

Fulfill the role of the Management Representative for Quality Management System and PRRC for the business (2017/746)

Ensuring the awareness of, and compliance to, regulatory (including IVDD, IVDR, 21 CFR 820) and customer requirements throughout the organisation

Ownership of the CAPA, Vigilance and PMS systems

Overall responsibility for the compliance and maintenance of the QMS including managing the audit programme (internal, supplier, customer, certification and notified bodies)

Lead and deliver the company quality objectives

Develop regulatory strategies for global markets, compilation of technical files and dossiers, and leading product registrations and submissions including CE marking, and international registrations

Discharge the role of regulatory and quality lead in design and development projects

Defining quality requirements for external suppliers and ensuring that these are met

Keep abreast of regulatory and quality requirements and changes and ensure they are transposed into the business

Create and maintain a quality and regulatory awareness training programme for the organisation

Serve as the quality champion in the business providing pragmatic regulatory and quality leadership to the business.

Serve as Official Correspondent and liaise with regulatory authorities where necessary

Any other responsibilities that may be required by the business

Knowledge and Experience:

Minimum of 5 years of Quality Management, Quality Assurance and Regulatory Affairs leadership experience in the medical devices including IVDs industry or pharmaceutical with responsibilities for managing others.

A four-year degree (an emphasis on health science or other technical field would be a plus) or demonstrated proficiency through Regulatory Affairs Certification (RAC).

Demonstrable knowledge and understanding of Quality Systems and Integrated Quality Management Systems

Proven experience of process / procedure / QMS development and implementation

Sound understanding of ISO 13485:2016, IVDD, IVDR, FDA 510k, MDSAP, 21 CFR 820

Ability to apply core quality tools and methodologies such as 8D, DMAIC

Experience with Qpulse QMS Software a plus

Skills:

  • Driven, proactive, confident and passionate about Quality
  • Ability to lead, co-ordinate and motivate
  • Ability to work independently under his/her own initiative.
  • Excellent communication skills required, written and verbal. Write procedures; perform presentations to staff and management.
  • Ability to work under pressure and to deadlines

Attentive to detail

promote a positive working environment conducive to a team atmosphere.

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