Head of Regulatory Affairs Medical Devices
1 month ago
**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.**
**Client Details**
The chance to work for a leading healthcare organisation.
**Description**
- 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
**Profile**
- Experience developing regulatory strategies is required and a strong understanding of new product development
- Knowledge of EU & International medical device legislation and quality standard requirements
- Experience of Quality & ISO Systems including ISO 13485 and MDSAP
- Lead Auditor qualified in quality assurance is desirable
**Job Offer**
Competitve package available
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