Consultant Medtech 50- 80%

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.
To support our clients engaged in the Medical Device industry, we are pleased to present the opportunity for the position of:
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) 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.

Candidate profile:
• 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.

We offer you
• 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.

This is an excellent opportunity for a proactive, results-oriented, and reliable professional looking to grow within a specialized and expanding consulting firm.

To apply, please send your CV and a brief cover letter.

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