Job opportunities

Job description

We are looking for a Regulatory Affairs Manager for a company that has focused on innovative solutions for the pure water supply of dialysis centers for almost 40 years. The company is active in Germany as well as globally. As a Regulatory Affairs Manager you will be extending their technology team.

KEY ACCOUNTABILITIES AND RESPONSIBILITIES 

• Create and update technical documentation for active medical devices following the European and international regulations.
• Conduct Risk Management and Clinical Evaluation for medical devices
• Be responsible for regulatory compliance according to Art. 15 MDR („PRRC“)
• Support their teams to understand and adopt regulatory and legal requirements for medical devices
• Plan and implement post market surveillance and reporting activities
• Update and improve their quality management system, develop procedures, and participate in audits

REQUIREMENTS  

• You have a degree in science or engineering (or similar)
• You have worked in the design and development, regulatory affairs or quality management for medical
• devices
• You know the details of legal and regulatory requirements for medical devices in Europe and, ideally, in other international markets.
• You have knowledge and, ideally, experience in risk assessments, clinical evaluation, and participated in the conformity assessment of medical devices
• Analytical thinking and precise comunication skills
• Good planning and self-organization skills
• High level of motivation and responsibility
• Systematic working approach, involvement, reliability and loyalty are important to you
• You speak German and English fluently