Regulatory Affairs Manager Location: Hamburg, Germany Salary: Flexible depending on level Job type: Permanent, full time
- Would you like to work in both product registrations and R&D projects within class I & II medical devices? - Eager to work for a stable company who work on a global scale with top level training/development? - Are you interested in developing and implementing a regulatory strategy?
Job reference: J24392 Regulatory Professionals have recently registered a new Regulatory Affairs Manager role with a hugely successful Medical Device company in Hamburg. This is a broad role involving regulatory strategy, product registrations and R&D Development projects. Due to the popularity of this company this role will likely move quite quickly! Responsibilities *Develop registration strategies for medical systems and new products *Coordinate all necessary regulatory affairs activities, including approval and maintenance, as well as coordination with the respective departments, suppliers and notified bodies *Ensuring compliance with regulatory requirements (MDD, FDA, PAL) in collaboration with the development departments during the product development process *Preparation of documentation for product approvals *Review and approval of development documents from the perspective of the Regulatory division Your qualifications * Profound experience in product registration of medical devices class I & II * Willing to work with R&D in development projects of mechanical devices * Knowledge of international regulatory requirements and other relevant standards * Excellent communication skills and fluency in both written and spoken English and German
Remember if this role is not suitable for you or you are no longer looking for a new job please feel free to forward this to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you £250 in vouchers of your choice. Key words: Regulatory, Regulatory Affairs, Medical Devices, Hamburg, North Germany, Endoscopy, Class I, Class I, Manager, Regulatory Affairs Manager