In Vitro Diagnostics Regulations Consultant - Contract!
Location: Berkshire, England
Salary: GBP60000 - 100000 per Annum
Job Ref: BRLO00001
Posted: 13/11/2020Apply Now
Regulatory Affairs Consultant / Officer
We have a fantastic role for an experienced Regulatory Affairs Consultant to join a fantastic Life Sciences company in Berkshire for a six month placement. This is an opportunity to work for a rapidly expanding niche Group of Companies that work within the proteins/reagents and diagnostics markets globally. Competitive salary package
As an experienced Regulatory Affairs Consultant you will be responsible for the Implementation of
In Vitro Diagnostic Regulation 2017/746 (IVDR) requirements, ensuring continued compliance with ISO 13485:2016 and Medical Device Single Audit Program (MDSAP) regulatory requirements. In addition you will closely with the Technical Director to ensure all regulatory requirements are met for existing IVD / Blood grouping reagents as well as the launch of new products. You will be responsible for writing SOP’s and technical files for IVD products, liaising with regulatory authorities and auditors.
As an experienced Regulatory Affairs consultant with this organisation you will need to have:
- At least 5 years’ experience in Regulatory Affairs in an UK based IVD Company.
- Working experience of registration of Annex II, List A, IVD products with EU Competent Authorities (including MHRA) in the last 5 years.
- Thorough working knowledge of the In Vitro Diagnostic Directive (IVDD) 98/79/EC.
- Certified Lead Auditor ISO 13485:2016.
- At least 3 years’ experience in implementation of ISO 13485:2016 and Medical Device Single Audit Program (MDSAP) compliant procedures in Quality Systems.
- Some experience with Health Canada Class III product registration.
- Knowledge of In Vitro Diagnostic Regulation 2017/746 (IVDR) requirements.
- Knowledge of blood grouping reagents / blood grouping practices is not a must, but will be a distinct advantage.
I this sound like the role for you then please send your CV via this job board in the first instance or contact elite recruitment on 01628 591800 or email email@example.com for more information.Apply Now