Team Leader Risk Management Medical Device 80 – 100 % (f/m/d)

As the Team Leader Risk Management, you will play a pivotal role in the mission to deliver innovative and lifesaving medical solutions. Leading and developing a dedicated team, you will oversee all aspects of risk management throughout the product lifecycle, ensuring compliance with regulatory standards and industry best practices. Your contributions will directly impact patient safety and the quality of care provided in critical care and intensive care units worldwide

Main Responsibilities: 

• Leading a team of Risk Managers; providing guidance, mentorship, and leadership; fostering a culture of excellence and collaboration; defining and executing strategic objectives and directions for risk management, aligning with organizational goals
• Training employees on Risk Management; conduct training sessions to educate employees on the principles of risk management and applicable standards and guidelines, ensuring a comprehensive understanding across the organization
• Ensuring Regulatory Compliance; enabling and ensuring the implementation and fulfillment of standards, regulations, and guidelines in risk management activities; maintaining compliance with ISO 13485, Quality System, MDR 2017/745, ISO 14971 Application of risk management to medical devices, IEC 62304 Medical Device Software, IEC 62366-1 Useability,
• Operational Risk Management; implement robust operational processes to identify, assess, and mitigate risks associated with medical device development and manufacturing, both local and overseas; emphasizing proactive risk mitigation strategies; utilize various tools and methodologies, including FMEA, to identify potential risks and develop appropriate risk mitigation plan
• Communication with test laboratories, authorities, and notified bodies; serve as the primary point of contact regarding risk management activities, ensuring transparency and compliance

That’s what you bring along: 

• Technical or scientific degree in engineering, biomedical sciences, or related field
• Several years of professional experience as a team leader with a demonstrated ability to motivate and develop high-performing teams
• Several years of professional experience in the medical device industry, preferably
• Strong background in risk management and its application for medical devices,
• Fluency in English and German languages, both written and verbal 

What you can expect

You will join an organization that is committed to making a meaningful difference in healthcare through innovation, quality, and patient safety and foster cooperation and open communication. Joining this organization means being part of a dynamic environment where your expertise will be valued, and your contributions will have a direct impact on improving outcomes for patients worldwide.

Ready to make a difference?

If you are a driven professional seeking a rewarding leadership opportunity and contributing to developing processes in a growing organization, we encourage you to apply.

Please send us your complete documents by email to E-Mail schreiben, for the attention of Andrea Nienaber, Managing Partner DE BORD INTERNATIONAL.

Discretion is a matter of course.

DE BORD INTERNATIONAL • Zürichbergstrasse 38 • CH-8044 Zürich
• Telefon +41 44 382 17 17 • E-Mail schreiben • www.debord.ch
• www.lladvisorygroup.com