Regulatory Affairs Specialist; M​/F​/D

Regulatory Affairs Specialist (m/f/d)

As an innovative and internationally oriented manufacturer of premium implants for eye surgery, we develop, produce and distribute medical products to restore the best possible vision to the human eye.

To strengthen our team at the Erlangen site, we are looking for a full-time Regulatory Affairs Specialist (m/f/d) to start as soon as possible.

• Approval and registration of medical devices in national and international markets
• Preparation of documents for certification and legalization
• Support in the maintenance and cooperation in the preparation of technical product documentation including risk management files as well as approval-relevant documents within the framework of international approval strategies
• Project support for the implementation of the requirements of the new EU Medical Device Regulation and support in maintaining the corresponding authorizations
• Contact person internally and for business partners for regulatory issues
• Regulatory assessment of approval-relevant product and document changes
• Support in the revision and creation of RA-relevant QM documents
• Support in ensuring compliance with all directives, laws and standards and country-specific requirements
• Researching guidelines and laws
• Close internal communication and coordination with other departments

• Successfully completed studies in engineering, medical technology or a scientific discipline
• At least 3-5 years of experience in product approval of medical devices in the regulatory area
• Knowledge of regulatory requirements (MDR, MDD, FDA, NMPA, EN ISO 13485, EN ISO 14971) for non-active medical devices
• Knowledge of risk management
• Knowledge of ophthalmology an advantage
• Confident handling of MS Office
• Very good knowledge of German and English
• Resilience during heavy workloads
• Structured, solution-oriented and independent way of working
• Ability to work in a team and assertiveness
• Strong service orientation, friendliness and professional manners

• Varied and responsible activities in an innovative and future-oriented company
• Independent area of responsibility
• Collegial support culture
• Short decision-making paths due to a flat hierarchy
• Family friendliness
• 30 days vacation per year
• Christmas and vacation bonus