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

Your profile

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

Our offer

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

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HumanOptics AG