Join Our Team at PMS Process Management System Ltd.
PMS Process Management System Ltd. is a consulting company located at BlueFactory Site in Fribourg, with operations across both the French- and German-speaking regions of Switzerland. Our expertise lies in providing comprehensive support to pharmaceutical, biopharmaceutical, and medical device companies, assisting them in achieving their regulatory and quality objectives.
Position: Consultant Medtech (m/f) 50-80%
Job Description:
- Provide Regulatory Affairs (RA) and Quality Assurance (QA) support for the medical device industry (MDR 2017/745, IVDR 2017/746, MedDO/ODM for Switzerland).
- Engage in 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.
- Act as Swiss Authorized Representative (CH-REP) and Person Responsible for Regulatory Compliance (PRRC) under MedDO Art. 54 on behalf of clients.
- Support business development and the acquisition of new client mandates.
- Work primarily from home with flexibility to travel to client sites across Switzerland and internationally as needed.
- Collaborate closely with clients to ensure a positive impact and sustainable results.
Candidate Profile:
- PhD, master’s, or bachelor’s degree in life sciences, engineering, or a related scientific field.
- A minimum of 2-3 years of experience in Regulatory Affairs and Quality Assurance within 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, with the ability to listen and interact 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.
- An entrepreneurial mindset, capable of working autonomously and managing multiple mandates within a dynamic consulting structure.
We Offer You:
- Exposure to a diverse range of projects and client environments that make a tangible impact on product compliance and patient safety.
- A flexible, home-office-first working model that promotes a healthy work-life balance.
- Continuous professional development opportunities, including access to training, regulatory updates, and industry events.
This is an excellent opportunity for a proactive, results-oriented, and dependable professional looking to grow within a specialized and expanding consulting firm.
Apply online using the form below. Only applications matching the job profile will be considered.
For any inquiries, feel free to contact Stéphane Gumy at +41 79 512 43 16 or via email at stephane.gumy@pmsystem.ch.
We look forward to receiving your application!
PMS Process Management System Sàrl
Passage du Cardinal 13b– 1700 Fribourg - Switzerland
Website: www.pmsystem.ch