EXTEND CONSULTING is a recruitment agency, we are hiring a HEAD OF REGULATORY AFFAIRS (M/W/D) for HUMANOPTICS Company.
AS an innovative and internationally oriented manufacturer of premium implants for ophthalmic surgery, we develop, produce and market medical products to restore the best possible vision to the human eye.
To strengthen our team at the Erlangen location, we are looking for a new colleague at the earliest possible date as.
- Preparation and maintenance of technical documentation for MDD/MDR approval
- Preparation of MD approval dossiers for international - outside of the EU - approvals
- Updating of the requirements for devices to be approved in the various target markets
- Correspondence with business partners and regulatory authorities on product approvals
- Monitoring and updating of the relevant standards and coordination of compliance assessment
- Organisation and support of auditors from authorities in/outside of the EU during audits at our company locations
- Product Change notification to Authorities
- Cross-departmental cooperation including but not limited to R & D, Clinical & Medical Affairs and QM.
- Successfully completed studies in engineering, medical technology or a scientific discipline
- Several years of experience in product approval of Class IIb medical devices
- Very good knowledge of regulatory requirements (e.g. MPG, MDD, MDR, FDA, CFDA)
- Experience in Ophthalmology is beneficial
- Experienced leader in a similar position
- Enjoying cross-departmental cooperation with R & D, Clinical & Medical Affairs, QM, ...as well as with Business Partners all around the world
- Very good command of spoken and written English. Confidence to communicate in an international and multicultural environment
- Structured, conscientious and efficient way of working
- High level of Initiative-taking and high sense of responsibility and accountability
We offer you an exciting and diversified job in an international growing medium-sized company with a positive, collegial and small hierarchical corporate culture. Remuneration is performance-related and encompasses holiday bonus, Christmas bonus and various social benefits including 30 days holiday per year.
Please send us your application documents stating your earliest possible starting date to the following address :
HumanOptics AG | Personalabteilung, Herr Saß | Spardorfer Str. 150 | 91054 Erlangen
Email : email@example.com and firstname.lastname@example.org