Found Description
PMS Process Management System Ltd. is a consulting company based at BlueFactory Site in Fribourg, with operations spanning both the French- and German-speaking regions of Switzerland.
Our specialization lies in providing comprehensive support to pharmaceutical, biopharmaceutical, and medical device companies, supporting them in achieving their regulatory and quality objectives.
Consultant Medtech (m/f) 50-80%
Job Description
- Regulatory Affairs (RA) and Quality Assurance (QA) support across the medical device industry (MDR 2017/745, IVDR 2017/746, MedDO/ODM for Switzerland).
- Challenging and varied technical assignments including risk analysis (ISO 14971), usability engineering (IEC 62366-1), QMS implementation (ISO 13485), design and development support, post-market surveillance (PMS/PMCF), and execution of audits.
- Acting as Swiss Authorized Representative (CH-REP) and Person Responsible for Regulatory Compliance (PRRC)...
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