Regulatory Affairs Manager EMEA - Medical Devices - Cork
Fabulous opportunity for a brand-new role with this rapidly expanding multiple national Medical Devices company.
This role will support the EMEA region and will suit a talented people Manager with excellent management skills, comfortable managing a number of people in different locations around EMEA.
Extremely exciting role for a dynamic and motivated team player with excellent experience of regulatory compliance to achieve favourable market access across EMEA.
- Line management of the local RA Specialists across the EMEA region.
- Support the preparation and coordination of registration submission planning and KPI reporting for the EMEA division in accordance with sales and marketing strategy.
- Analyse and monitor registration activity to ensure performance is in line with objectives and communicate performance to the business.
- Act as the franchise lead for assigned product portfolios, supporting the preparation and compilation of compliant registration dossiers to secure market access and assessing impact of product changes to registration approvals throughout the product lifecycle.
- Work in collaboration with EMEA Marketing teams to ensure market clearance / access issues are resolved so that new product launches are planned in line with business expectations and changes affecting market clearance are managed.
- Ensure alignment between the EU MDR Central Economic Operator team and EMEA registration processes.
- Subject matter expert on EMEA regulations and policies and provide advice / training to the commercial teams and international Design Divisions.
- Act as Divisional Process Owner on EMEA projects around pre-market activities.
- Represent Regulatory Affairs in Merger and Acquisition activity to ensure successful RA integrations across EMEA.
- Support pre-market process improvement projects and ensure effective transposition of Corporate SOPs at divisional / local level.
- Support international or Corporate RAQA projects.
- Deputise for Senior RA Manager EMEA where necessary.
- Fluent in English
- Degree graduate (Science / Engineering / Legal / Business fields)
- Advanced qualifications in Regulatory Affairs (RAC, MSc etc) preferred
- Member of RAPS / TOPRA
Regulatory Affairs, Regulatory Submissions, People Management