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All vacanciesRegulatory Affairs Manager
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