Head of Regulatory Affairs (Medical Devices)
- Employer
- Michael Page
- Location
- England, Bristol
- Salary
- Negotiable
- Start date
- 22 Nov 2022
- Closing date
- 29 Nov 2022
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Senior Management
Job Details
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
Job Offer
Competitve package available
Company
The original PageGroup brand, Michael Page is comprised of 25 disciplines – each providing a service to a specialist area of the market. We recruit permanent, temporary, contract and interim opportunities, typically from second/third job levels upward. Businesses we work with range from SMEs to global blue-chip organisations.
The UK
Our business started life in the UK in 1976, as a two-man operation above a laundrette. Nearly four decades later we have more than 7000 employees and a global office network, while growing our UK market coverage too.
With offices from Aberdeen to Bristol and Cardiff to Cambridge, and more than 25 specialist businesses we have the track record to handle your recruitment requirements or job search. We combine our local knowledge and global expertise to provide a specialised service to both employers and candidates.
- Website
- https://www.michaelpage.co.uk/
- Telephone
- 0845 6060 610
- Location
-
Michael Page International Ltd,3rd Floor
The Switch Building
1‑7 The Grove
Slough
SL1 1QP
GB
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