Consultant Medtech; m​/f

PMS Process Management System Ltd. is a consulting company based at Blue Factory 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.

• 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) under MedDO Art. 54 on behalf of clients.
• Support for business development and acquisition of new client mandates.
• Mainly home-office-based with flexibility to travel to client sites across Switzerland and internationally as needed.
• Close collaboration with clients to ensure positive impact and sustainable results.

• PhD, master’s or bachelor’s degree in life science, engineering or related scientific field.
• Minimum 2-3 years of experience in Regulatory Affairs and Quality Assurance in the medical device industry (EU MDR 2017/745 and/or IVDR 2017/746).
• Experience with country/national registrations (Switzerland, EU, and/or international markets).
• Solid audit experience: supplier audits, internal audits, and certification audits; proven ability to lead and manage audit programs, including interactions with Notified Bodies (e.g. DEKRA, BSI, TÜV). Required languages:
  French or German (mother tongue);
  English (fluent). Italian is an asset.
• Strong communication and presentation skills, capable of listening and interacting effectively with clients, staff and regulatory agencies at all organizational levels.
• Experience in either Clinical Affairs or Software as a Medical Device (SaMD) is an advantage.
• Entrepreneurial mindset, able to work autonomously and manage multiple mandates simultaneously within a dynamic consulting structure.

• Exposure to a wide range of projects and client environments, with real impact on product compliance and patient safety.
• A flexible, home-office-first working model promoting a healthy work-life balance.
• Continuous professional development: access to training, regulatory updates, and industry events.

PMS Process Management System Sàrl