At Olympus, it's the people who advance the development of innovative solutions. By their dedication in the fields of Cameras and Voice Recorders, Endoscopy and Microscopy we have become the globally leading manufacturer of opto-digital technology. All over Europe our employees turn our ideas into reality every day. Moreover, we provide an excellent framework and a pleasant working atmosphere.
Join our international team in Hamburg to further strengthen our solid market position.
Key Activities:
- Coordinate documents for product registrations and registration renewals for European markets with focus on the emerging markets
- Monitor and set timelines for licence variations and renewal approvals
- Review product labelling
- Negotiate with regulatory authorities for marketing authorisation
- Advise markets and manufacturers on regulatory requirements
- Liaise with and make presentations to regulatory authorities
- Coordinate vigilance/CAPA activities and follow-up with manufacturers, country organisations, competent authorities and notified bodies
- Support Medical Device Safety Officer according to Medical Device Act
- Lead project managing teams of colleagues involved with the development of new products
- Keep abreast of international legislation, guidelines and customer practices in all countries to which the company is exporting
Your Profile:
- At least 3 years' experience in regulatory affairs and quality management of medical devices (MDD, ISO 13485)
- Practical knowledge of medical device registration in Europe
- Fluency in English and German (verbal and written)
- Analytical and problem-solving skills
- Strong communication skills (written and oral)
- Team player with networking skills and ability to get on with a wide range of people
- Project management skills
Join Olympus. Apply now, preferably via
www.olympus-europa.com
Olympus Europa Holding GmbH
Human Resources, Ms. Karolin Schubach
Wendenstr. 14–18, 20097 Hamburg, Germany
Phone: +49 40 23773-4626
Olympus is an equal opportunity employer.
