We are one of the leading German manufacturers of high quality products for medical devices in the fields of rehabilitation, sports and aesthetic medicine.
We have been active on the market since 1973, employ around 70 people and export our products to over 83 countries worldwide.
We are looking for the next possible date a
Head of Regulatory Affairs (m/w/d)
What are your responsibilities?
- Technical leadership of the team
- Interface with relevant departments (R&D, PM, IM, Sales, Prod, MaWi) and the GF
- Maintaining and obtaining approvals and registrations necessary for the distribution of medical products
- Planning, initiation, coordination and evaluation of internal quality management projects including facility-related and/or cross-facility working groups and/or quality circles
- Continuous initiation and implementation of improvement measures
- Continuous further development of the QM system to ensure compliance with DIN ISO 13485
- Performing the role of the designated person under MDR, if applicable
Safety Officer - Planning and execution of internal and supplier audits to monitor the QM system
- Contact person for the notified bodies and audit representative for external audits
- Direct reporting to the management on the development status and effectiveness of the QM system
- Advising management on the development of quality objectives and policy
- Monitoring compliance with legal and regulatory requirements within the company
- Continuous initiation and implementation of improvement measures
- Coordinating the creation, monitoring and control of the
- Quality Management Manual as well as the documents and records of the QM system
- Handling of customer complaints in cooperation with other process managers
process owners - Management of the QM system
- Conducting internal and supplier audits
- Carrying out product inspections for conformity with the existing quality management system before product release
- Preparation or continuous updating of technical documentation and EU declarations of conformity
- Fulfillment of the obligations resulting from the post-market surveillance of the
medical devices after they have been placed on the market - Fulfillment of reporting obligations resulting from vigilance requirements, Declaration of “safety” of investigational devices for clinical trials.
- Fulfillment of vigilance requirements according to MDR.
What you bring to the table:
- Technical degree or training with many years of professional experience in the field of QM – preferably for medical devices
- Training as quality manager; preferably manager regulatory affairs
- Very good knowledge of standard 13485, regulatory requirements for medical devices and MDD/ MDR
- Experience in project management
- Experience in process management
- Experience in conducting audits
- Leadership experience
- English language skills
We offer:
- Versatile and varied tasks
- Independent and autonomous work
- Creative and team-oriented working atmosphere
- Fair, performance-related remuneration and corresponding
- development opportunities
- 30 days vacation (with a 5-day week)
If you would like to become part of our team, please send your complete application documents (preferably by e-mail) with details of the earliest possible starting date and salary expectations to: karriere@physiomed.de.
We look forward to hearing from you!