This role reports to Corporate Director QMRA
Regulatory Affairs Manager oversees the regulation process for products requiring governmental approval, including filing necessary applications and registrations according to the Medical Devices regulation, handling all interactions with Notified Bodies. Supporting the Quality Management and Operational teams, and develop procedures to ensure regulatory compliance.
What will you be doing at STS?
- Driving and supervising the MDR readiness activities in cross-functional work-packages
- Developing registration strategies on a corporate level and breaking them down to local deliverables
- Monitoring timely execution of the strategies and develop KPIs
- Supervision and final sign-off on conformity assessments
- Develop a corporate standard for the content and format of the technical documentation
- Liaison with Notified Bodies and competent authorities
- Responsible for the development of corporate best practice procedures for compliance with the current and future MD regulations in Europe (MDD and MDR).
- Driving and supervising the research and actualization of applicable Norms
- Supporting the development of corporate best practice procedures for compliance with Quality System requirements and monitor the local implementation
- Supervise product releases/notification at national EU databases
- Proactively engage and develop the compliance awareness on a corporate level and break it down to deliverables in the local organisation (determine training needs, develop training and coach and mentor local RA organisation to deliver the training on the local level)
- Implementation and execution of international product registrations strategies
- Develop audit standards for RA compliance of crucial subcontractors
- Lead and support audits by Notified Bodies and competent authorities
- Actively monitor the regulations and guidance documents in the Medical Device area and inform and train the organisation in case of changes or new requirement
- Support QA department regarding ISO certifications and audits.
To be successful in this role, you must have
- Excellent knowledge of current Medical Device legislation, standards, and Guidance (such as MDD, ISO 13485, ISO 14971; ISO 10993, MED DEV 2.7.1.)
- Excellent understanding of the implications of the new MD regulation (MDR)
- Experience in leading and contributing to regulatory organisations in an international environment
- Experience in managing teams in a Matrix organisation
- Excellent understanding of the Quality system requirements for manufacturing and marketing medical devices
- Experience in developing KPIs and reporting instruments
- Previous experience of matrix management of key commercial projects
- Scientific or technical background, Graduate degree preferred
What does STS offer you?
Diversified range of activities in an international environment and ability to be part of a young and dynamic team. You will work in a flexible, continuously growing organization.
This role is based in Germany preferably area of Horb am Neckar
Please send your application to email@example.com