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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
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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

  • 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

    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.

    LinkedIn award

     

    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.

    Find Us
    Website
    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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