Regulatory Affairs Specialist - Bonaduz
Crystal Spilsbury at CK QLS is recruiting for a Regulatory Affairs Specialist to join a company in the Medical Device industry at their site based in Bonaduz on a permanent basis.
Our client is a Medical Device company focused on Ventilation machines. This role is based in their site in Bonaduz.
The main purpose of the role will be the:
- Supervision of product managers throughout the life cycle of the products in a regulatory sense and the fact that the technical documentation of the products complies with the European requirements for medical devices
- Self-responsible representation of quality aspects and quality regulations as well as normative and legal requirements as well as communication of new legal approval requirements and support in implementation
- Creation of 510 (k) Submissions and Health Canada licence applications
- Biological evaluation of the products according to ISO 10993 and ISO 18562
- Creation and execution of tests
Supervision of risk analysisFurther responsibilities will include:
Supporting for international approval according to internal definition Requirements:
Communication with external testing institutes
- Examination of the completeness and correctness of project documentation
- Conducting reviews
- Standards Research
To succeed in this role, you will come from a background in:
- Scientific, electrotechnical or medical direction or completed vocational training plus at least 5 years of practical experience and additional continuing vocational training (e.g. master, Technician, technical diploma)
- International approvals in the field of medical devices especially MDD (in future MDR), 510 (k) and Health Canada
- Professional experience in regulatory affairs/quality
- Biological assessment according to ISO 10993 and ISO 18562 is advantageous
- Knowledge of IEC 60601-1 series of advantages
- Quality management, development, testing and production of medical devices is an advantage
Fluency in German and English is essential for this role.
For more information or to apply for this position, please contact Crystal Spilsbury on +44 1438 905 156 or email cspilsbury@ckqls.ch Please quote reference QLS43333 in all correspondence.