The Head of Regulatory is responsible for Regulatory compliance and Quality management systems of the Medical Devices businesses covering new product development, manufacturing, distribution and commercial activities.
The chance to work for a leading healthcare organisation.
- To lead and manage regulatory affairs requirements of the Medical Device portfolio in accordance with strategy
- To act as the following to support the businesses:
- Person with Responsibility for Regulatory Compliance (PRRC) as per Medical Device Regulations 2017/745
- UK Responsible Person as per UK MDR 2002 as amended
- To oversee the Quality Management systems to maintain certification within UK, EU and internationally including:
- ISO 9001/ISO 13485/MDSAP certification
- Economic Operator requirements
- Complaints, Vigilance, Field Safety Corrective actions & Post-marketing surveillance
- Supplier qualification and performance management
- Distributor onboarding and compliance
- QMS processes incl change control, NC/CAPA management, audit and training programmes
ProfileExperience developing regulatory strategies is required and a strong understanding of new product development Knowledge of EU & International medical device legislation and quality standard requirementsExperience of Quality & ISO Systems including ISO 13485 and MDSAPLead Auditor qualified in quality assurance is desirable
Competitve package available