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.
§ 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
- 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.