SIS (Swiss Interventional Systems) Medical AG is a global, innovative and rapidly growing company in the field of medical device technology and was founded in 2007 in Winterthur, Switzerland.
SISMedical AG is the inventor of the unique OPN NC – the Super-High-Pressure PTCA balloon. The company’s proprietary TWIN-Wall technology facilitates the manufacturing of high-performance interventional coronary balloons, which can be inflated up to 35 atm.
SIS Medical has achieved significant progress in development and implementation of Quality Management System and Regulatory compliance. The achievements in last three years include: Successful MDR and MDSAP audits, GMP-certification in Brazil and US FDA clearance of the strategic product of the company.
Today the products of SIS Medical are sold in more than 50 countries. The US FDA clearance of the OPN NC in 2022 opened a large new market for SIS Medical AG and has made the innovative TWIN-Wall technology available to US patients.
As part of the succession process, we are looking asap for a creative and communicative personality with a solution-oriented and structured work methodology in the position of a
Head of Quality Assurance/ Regulatory Affairs (m/w/d, 100%)
Your Tasks
Management Representative for SIS Medical AG
Full responsibility for the QA / RA department including but not limited to:
Maintain and improve companie’s Quality Management System
Design, Implementation and continuous improvement of Quality Management processes according to the requirements of MDR, MDR and MDSAP
Responsible for RA processes such as Regulatory Affairs Strategies, International Submissions, Vigilance System - Complaint Handling (incl. MDR, FSN and FSCA) and Post Market Surveillance
Responsible for Regulatory Compliance (PRRC) for SIS Medical AG in Switzerland
Prepare and Conduct regular Management Reviews
Responsible for monitoring and compliance with all processes in accordance with the Q manual
Responsible for the continuous improvement process
Monitor, assess and implement new relevant norms and standards
Further develop existing team of six employees in QA / RA department
Performing internal and external audits
Assessment, initiation and monitoring of deviations and CAPA's
Representation of the QA / RA department in development projects
Responsibility for risk management process
Improve complaint management process, implement relevant KPIs.
Contact with Notified Bodies and National Competent Authorities, as well as distributors
Your Profile
University or Applied Science College with a degree in natural sciences or technology
At least 10 years of experience in the field of QA / RA in medical technology. Thereof at least 5 years with personnel responsibility.
Flexibility, "hands-on" and "can do" attitude, leadership qualities, pro-active and business oriented personality.
Good knowledge of MS Office applications
Fluent in writing and speaking in German and English (B2, C1)
Independent, resilient, flexible, reliable, structured and solution oriented
Team player, creative and assertive
We offer a culture characterized by collaboration, performance, and helpfulness and except you to work in a young, well-positioned, innovative company with a lot of pioneering spirit. In addition to challenging and diversity of tasks in an international environment, we offer an opportunity for further development within our dynamic and rapidly growing team.
If you share our passion for outstanding achievements in medical device technology, then please send your complete application documents to:
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