A new opportunity has been created for a senior expert to act as Head of Regulatory Affairs and provide strategic, scientific expertise to support regulatory activities leading to successful approval of portfolio of products.
Support internally review groups to develop the required clinical performance/ clinical evaluation reports for the various product lines including the clinical strategy according to the require standards.
Develop appropriate clinical performance trials and Post Market Clinical Follow-ups including assisting with plans, protocols, end point design.
Support Technical Validation Group to determine the usability of products based on the usability standards (ISO 62304) and MHRA guidelines.
Co-ordinate and file MHRA submissions for new performance trails
represent the regulatory department at clinical evidence forums/meetings
manage outsourced clinical performance experts
Develop and or obtain stability study reports
Perform other Regulatory and Quality activities as required
Prior experience in consolidating clinical evidence, usability, and stability evidence
IVDD or MDD experience
Experience with ISO 14971:2019, EN 13612:2002 - Performance evaluation of in vitro diagnostic medical devices ISO 62366: ISO 13485:2016 Quality, Management system experience MEDDEV 2.7/1 revision
Solid team management and leadership experience
Prior track record of successful submission management and direct contact with health authorities
Michael Bailey International is acting as an Employment Business in relation to this vacancy.