Stellenbeschreibung

Head of Quality Management and Regulatory Affairs  - Munich - Permanent – €130.000 +   My client is a medical device company with over 25 years’ experience in manufacturing Class I and II medical devices. I am currently recruiting for the role of Head of Quality Management and Regulatory Affairs for their offices in Munich. The ideal candidate will have extensive regulatory and quality experience in medical device industry and is fluent in English and German.       Responsibilities:   • Maintaining and developing the quality management system of the company according to the requirements of the MDD, ISO 13485: 2003, cGMP and 21 CFR 803, 806, 820• Responsible for monitoring and optimization of processes and documentation• In charge of supporting the managerial division by performing an active risk management• Be the liaison between the R&D department, production, service, product management, QM and RA departments• Manage and coordinate all staff for the implementation of legal and quality-related requirements, standards and quality documents• Perform internal and supplier audits • Performance of Compliance Management• Responsible for performing global registration for approval of the company’s products. • Represent the primary liaison of  all worldwide authorities with regards to audits / inspections, reportable events and marketing applications• Support the  R&D department with regards to the applicable standards and required documentation for regulatory submissions   Requirements: • A good BSc in Science, Engineering or a relevant Life Sciences discipline• Relevant experience in a similar position in the area of ​​Quality management, medical technology (equipment and / or disposables is a great advantage)• Sound knowledge of Medical Devices Act, FDA requirements, GMP requirements• Minimum 5 years’ experience in project and risk management• Extensive experience in the introduction and implementation of quality improvement processes and the application Related QS systems and methods• Fluency in English and German  The company is medium sized but with a strong international presence. They have several new projects and need an experienced Senior Regulatory and Quality professional to help them handle all new projects as well as the ongoing ones. If you believe that you fit the requirements and feel ready to take over the responsibilities, then don’t hesitate to apply for this position.