Head of Quality Assurance/ Regulatory Affairs (m/w/d, 100%)
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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Frauenfeld / CH-8500 Frauenfeld
