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.
- Website
- https://barringtonjames.com/
- Telephone
- 01293 776644
- Location
-
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
GB
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