Regulatory Affairs Manager (m/w/d)

• Implementation of the MDR 2017/745, associated guidelines and standards
• Creating and maintaining technical documentation for existing products and new developments.
• Communicating with the responsible approval authorities and notified bodies
• Carrying out conformity assessment procedures
• Keeping up with developments in the field of regulatory requirements and implementing measures to meet them
• Supporting the creation and development of sales-supporting materials (product brochures etc.).
• Close cooperation with the sales and marketing team as well as regular meetings with related departments
• Building up product-specific expertise and passing on that knowledge into the company

• Completed studies in the field of medical technology ,industrial engineering or product engineering or a comparable qualification.
• Experience in project management is an advantage
• Very good understanding of applications and resulting customer requirements
• Knowledge of the standards governing medical technology
• Strong customer orientation
• Pragmatic and analytical approach
• Confidence and assertiveness

As a reliable employer we support our Königsee team with a host of prospects and flexible offers for all phases in life. Discover us:

• A structured and detailed initiation at the company sites where a mentor will support you.
• Varied and responsible tasks including decision pathways and a flat hierarchy
• A future-proof and permanent job in a growing company
• A family-oriented and social personnel policy, incorporating flexible working hours, for instance, ensures a healthy work-life balance
• Sustainability and responsibility for future generations is incorporated into the day-to-day running of the business
• Open company structure
• Free parking
• Water dispensers
• Monthly vouchers
• Company pension
• …. And much more

Vacancy