Regulatory Affairs Specialist

Regulatory Affairs Specialist

Are you passionate about bringing life-changing medical devices onto the market on an international scale?

Join our client, a market-leading developer, manufacturer, and distributor of implants and devices for ophthalmic surgery with over four decades of history.

Apply now and use your skills to help restore the best possible vision to patients worldwide!

Role Incentives

• Varied and responsible activities in an innovative and future-oriented company
• Collegial support culture
• Flat hierarchies & Short decision-making processes
• Family friendliness
• 30 days of vacation per year
• Christmas and holiday bonuses

Your Key Responsibilities

• Approval and registration of medical devices globally
• Preparation of certification and legalization documents
• Maintenance and development of technical documentation, including risk management
• Support for EU MDR implementation and approval
• Regulatory contact for internal teams and business partners

Requirements

• Successfully completed degree in engineering, medical technology or similar
• Min. 1-3 years of experience in medical device Regulatory Affairs
• Knowledge of regulatory requirements e.g. MDR, MDD, FDA, NMPA, EN ISO 13485, EN ISO 14971
• Resilience, structured, solution-oriented and independent way of working
• Ability to work in a team and assertiveness
• Strong service orientation, friendliness and professional manners
• Confident use of MS Office
• Very good knowledge of German and English

Ophthalmological knowledge is a plus!

If you are interested in this role, please apply with your CV or contact Vivien Zsuzsanna Urban for further details on this opportunity.

Email: vivien.urban@adaptivelifescience.com

Phone: +49 30 16639819