Regulatory Affairs Specialist
Job title- Permanent
This global market leading client of Med Tech Professionals is looking for a Regulatory Affairs Specialist to join their company, based in Hamburg. The company specialise in the production of Medical Devices, specifically endoscopes and are looking for a dynamic candidate to join their company. The ideal candidate would have a market knowledge of Asia and a keen interest within this market.
Coordinate complete measures for the approval of the company medical systems in line with the sales organizations
Inclusion of country-specific registration requirements and their transfer into the organization
Prepare documentation for the country-specific product approvals
Support international sales organizations in the handling of the approvals
Communication with international sales organizations at all regulatory relevant product changes
Examine and approve documents in line with the Regulatory Affairs standards
University degree, preferably within Life Sciences or similar
Knowledge of international licensing requirements for the Asian room
2 years` experience working within Regulatory Affairs, ideally within the Medical Devices industry.
Knowledge of the relevant standards (ICE 60601, 62304 etc.)
English and German spoken to a native level. Mandarin, Cantonese or Japanese would be a bonus
If this role is not suited to you, please feel free to share the details within your professional network as we do operate a generous bonus referral scheme should we then go on to place someone that you recommend to us.
Regulatory Affairs, Germany, Hamburg, Medical Devices, IVD, ICE 60601, ICE 62304, East Asia, Asian Markets, Japanese, Mandarin, Cantonese, German, English, Life Sciences,
- Regulatory Affairs Specialist