Job Reference: J5631345
Updated On: 17/04/2019
Status: Now Interviewing
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Role OverviewHyper Recruitment Solutions are currently recruiting for an experienced Medical Device Regulatory Affairs specialist to join a Diagnostics company based in Kent. They are looking for an In Vitro Diagnostic specialist to join their team for a 12 month Fixed term Contract to ensure the compliance of their Regulatory Documentation to the new In Vitro Diagnostic Regulation (IVDR).
Key Duties and ResponsibilitiesYour duties as the Regulatory Affairs Specialist - IVD will be varied however the key duties and responsibilities are as follows:
1. Compile documentation and information to support IVDR requirements for Technical Documentation Files (TDFs).
2. Work Cross-functionally with internal departments to ensure information is correctly obtained to support the TDFs.
3. Maintain and update working knowledge of new and existing regulatory procedures and changes to ensure that other staff members are compliant.
Role RequirementsTo be successful in your application to this exciting opportunity as the Regulatory Affairs Specialist - IVD we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences or related field in addition to Regulatory Affairs experience, ideally within Medical Device Regulations.
2. Proven industry experience in the In Vitro Diagnostic industry is preferable, ideally within Regulatory Affairs.
3. A working knowledge and practical experience with CE Technical Files, Good Documentation Practise (GDP) and the IVDR would be beneficial to your application.
Key Words: Medical Device Regulation | MDR | In Vitro Diagnostic Regulation | IVDR | Technical Documentation Files | TDF | CE Marking | CE Technical Files | IVD | GDP | Good Documentation Practise | Compliance
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