Regulatory & Quality Manager
Website headcount AG
Regulatory Affairs Manager
Are you ready to take on this challenge working with a complex light emitting Medical Device applied for pain and cosmetic needs. Our client in Schwyz and/or Neuchatel needs your support to ensure compliance of their products being registered globally and undertake hybrid tasks of managing their internal Quality systems. In order to excel in this role, you will need to perform:
Quality Management
- Further development and implementation of quality management system (QMS) (ISO 13485, MDSAP, CFR 820, SOR/98-282)
- Deputy to the Quality Management Representative, provide Quality Management support on the projects
- Conduct internal audits as per audit program
- Support and assist the company on 3rd party (external) audits from Notified Bodies and regulatory bodies (notified body, ETL-certification, Swissmedic)
- Conduct risk and root cause analyses. Define and implement CAPAs
- Perform the corrective measures resulting from audits (ISO 14971)
Regulatory Affairs
- Lifecycle management and maintnance of Technical documents
- Review and update of all product related printing materials (IFU, labels, packaging, leaflets)
- Keeping up to date with changes in regulatory legislation and guidelines
- Guarantee of compliance of all products in all requested countries
- Responsibility for all vigilance duties pursuant to current regulations (EEC/93/42, (EU) 2017/745, ISO 13485, MDSAP, FDA-QSA, Health Canada, etc.)
- Deputy to the Responsible for regulatory compliance according art. 15 MDR (PRRC)
- Registration of new products in all requested countries and manage all current product registrations worldwide
Qualifications
- A minimum of 3 years experience in quality management in the field of industrial production, international regulatory and risk management of medical device (Class II)
- Good knowledge of ISO 13485,ISO, MDSAP, EN ISO 14971:2020, MDR 2017/745, and CRF regulations
- Hands-on experience and sound understanding of the European processes
- Fluent in English, French is an advantage
Drop me a mail at dani@headcount.ch if this sounds like the next step in your career.