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Quality and Regulatory Affairs Manager

  • Location

    Glasgow, Scotland

  • Discipline:

    Operations

  • Type:

    Permanent

  • Salary:

    Up to £35000.00 per annum

  • Contact:

    Craig Grainger

  • Expiry date:

    29-07-2020

Quality and Regulatory Affairs Manager
 

Do you have experience using medical devices within an R&D environment?
 

Are you familiar with Regulatory standards including CE Mark and FDA 510K?
 

Have you previously facilitated annual clinical reviews?


MacGregor Black are partnering with a Research and Development Consumer Company on the search for a Quality and Regulatory Affairs Manager. This is a permanent role based in Glasgow.
As the Quality and Regulatory Affairs Manager you will co-ordinate the day to day management of the Quality Management System and Regulatory Affairs

Key Responsibilities:

  • Manage the implementation and maintenance of the Quality Management System to ISO 13485, ISO 9001 and CFR 820
  • Process development and improvement
  • Delegate Authority on QMS Documentation sign off representing CEO
  • Coordinate CCA / CAPA process, update CAPA log with NC data
  • Tracking and updates to training matrix / records
  • Develop and maintain material safety records and write appropriate risk assessments
  • Build relationships with suppliers and help develop incoming material quality standards
  • Manage the registration and maintenance of regulatory issues including initial registration in Europe (CE Mark), USA (FDA 510K), appropriate regulatory submissions in SE Asia and other areas globally
  • Build and Compliance review of established and new Technical Files
  • Facilitate Annual Clinical Review
  • Maintenance of regulatory updates in the design and manufacturing processes
  • Coordinate Management Review Meetings
  • Prepare Audit Plans
  • In role of Internal Auditor, conduct audits of internal operations in accordance with planned arrangements
  • Compile and report on audit findings NCR/OFIs to CEO
  • Contact auditee to establish implementation of solution(s) and verification of closure
  • Liaison with Notified Bodies for all visits and regulatory affairs



What we are looking for:

  • Experience with medical devices
  • Ideally from a Research & Development or Manufacturing background


Salary on offer is up to £35k + Benefits.
Please contact Craig Grainger today for further information.