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Regulatory and Quality Expert

Employer
Barrington James
Location
Homeworking
Salary
Flexible, Dependent on Experience
Start date
1 Dec 2021
Closing date
31 Dec 2021

View more

Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

The Company:

My world class Medical Device client is an industry leader with over 43,000 employees worldwide, operating in over 100 countries. They provide a systemic approach to Quality Assurance, and are designated to certify products according to the EU Medical Device Directive (MDD 93/42/EEC), EU Medical Device Regulation (EU) 2017/745 and ISO 17021/13485.

 

Responsibilities:

  • Responsible for informing notified body personnel of regulatory Intelligence i.e. relevant legislation, guidance and best practice documents including activities of relevant notified body coordination groups
  • Development and support for the implementation of procedures for the operation of the Notified Body.
  • Lead and support Corrective and Preventative Action (CAPA)
  • Perform investigations related to the handling of Complaints / Disputes
  • Monitor the performance of processes through execution of internal audits
  • Actively support quality leadership in monitoring and improving the quality system by driving continuous improvement
  • Provide support for management review activities
  • Escalate quality related issues to the Quality Manager

 

Requirements:

  • You should have either an appropriate degree, college degree or other qualifications and/or experience in either Health Science, Engineering or Quality/Regulatory disciplines related to the Medical Device or Pharma industry sectors
  • 3 years’ experience of either working in a Health Science related industry in Design, Manufacturing or Quality and Regulatory functions, or previous experience with either Management System registrars, Notified Bodies or Testing laboratories
  • Has knowledge of the EU Medical Device Directives and Regulations, ISO Accreditation and Quality Management Systems
  • Fluent in English written and spoken, fluent in Swedish is nice to have

 

 

Apply:

By applying, your CV will come directly to me and we can arrange a good time for us to speak on the phone to discuss your suitability for this opportunity (among others) and start the application process. Contact me on nskouros@barringtonjames.com | +44 (0) 1293 77 66 44

Company

We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.

Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.

Company info
Website
Telephone
01293 776644
Location
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
GB

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