Job opportunities

All vacancies

Regulatory 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

Contract

Executive search

Experience

Minimum 2 years

Education

Higher Scientific Degree

Languages

English, German

Sector

Other

Region

Bade-Wurtemberg

Job Type

Full-time

Submit your CV

Please submit your CV through the form below and we will contact you shortly.

How can we help

Drop by for
coffee