Head of Regulatory Affairs Medical Devices - Bristol, United Kingdom - Page Group

Page Group
Page Group
Verified Company
Bristol, United Kingdom

2 weeks ago

Tom O´Connor

Posted by:

Tom O´Connor

beBee Recruiter
Description

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 2017/74
  • 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 & Postmarketing 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
More jobs from Page Group
See all jobs of Page Group