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Vacancy: Quality/Regulatory Manager image
  • Job Title: Quality/Regulatory Manager
  • Reports to: Head of Regulatory Affairs
  • Salary: £34,637 (NHS Band 6, Point 2)
  • Location: Flexible – blended home and head office
  • Hours: Full-time
  • Contract: Two year fixed-term
  • Closing date: Friday 30 July

Scottish Health Innovations Ltd (SHIL) works in partnership with NHS Scotland to identify, protect, develop and commercialise healthcare innovations to improve patient care. SHIL is funded via a grant from the Chief Scientist Office (CSO) of the Scottish Government.

Purpose

To carry out a range of quality and regulatory activities associated with medical device development from initial selection through to commercialisation.

Role Overview

Working closely with the Project Management and Innovation Management teams on the support of innovation across NHS Scotland, the quality/regulatory manager will be responsible for the implementation and maintenance of the company Quality Management System (QMS) and quality/regulatory activities for the development of innovative products or technologies. Candidates should have a degree (or equivalent) certification in a science related, medical, or engineering discipline with a comprehensive understanding and experience of implementing ISO 13485:2016. Strong interpersonal and good team-working skills are also essential.

Specifically, this position has the following responsibilities:

  • implement and maintain the SHIL QMS
  • provide an appropriate regulatory framework for the development of products or technologies disclosed to SHIL
  • promote SHIL and its remit to the NHS, academia, industry and other groups and encourage collaboration
  • provide quality/regulatory services to SME, academia and NHS organisations

Key Activities

  • Provide accurate and current medical device regulatory and quality management advice to NHS, academia and SMEs
  • Prepare, review, and approve documentation for use in regulatory technical files in accordance with UK/EU/US requirements for medical devices and IVD's
  • Manage the development of medical devices within a framework suitable for appropriate regulatory requirements
  • Conduct and advise on internal and supplier audits
  • Provide support to the SHIL innovation and project management teams to maintain compliance with QMS
  • Offer regular communication with clients to provide accurate updates on regulatory changes that could affect their businesses
  • Provide strategic and technical advice contributing commercially and scientifically to the success of medical device development

Experience and Skills

Minimum Required

  • Degree/equivalent certification in a science-related, medical, or engineering discipline
  • Comprehensive understanding and implementation of ISO 13485:2016
  • Substantial regulatory experience within the medical devices sector - Manufacturing and/or Consultancy
  • Substantial experience in the compilation and review of technical documentation for UKCA / CE marking
  • An advantage would be experience in Clinical Evaluation compilation to current MEDDEV guidance and Risk Management implementation to medical device standard ISO 14971
  • Knowledge of electrical, usability, biocompatibility and software safety standards
  • Internal/Supplier Auditing experience
  • Report writing skills
Technical competencies Essential / Desirable
Project management skills E
Understanding of the role of innovative technology in business success D
Experience of engaging with staff at all levels in the healthcare sector D
Understanding and dissemination of complex technical data E
Experience of working within an ISO13485 QMS E

 

Core Competencies Essential / Desirable
Communication E
Adaptability / Flexibility E
Planning and Organising E
Continuous Personal Development E
Problem Solving and Decision Making Skills E
Creative and Analytical Thinking E
Influencing, Persuasion and Negotiation Skills E
Strategic Thinking & Leadership D
   
Special requirements  

Willingness to travel extensively and regularly throughout Scotland (full driver’s
license and access to fully insured car essential)

E
Occasional travel to rest of U.K. and overseas E
Occasional work out-with core hours E
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