Associate Director RA Instrumentation

Do you want to make a significant difference in how the world is looking tomorrow and contribute to the innovation of state-of-the-art, cutting-edge technology products?
Then look no further and join our Quality & Regulatory team at Männedorf, Zürich as

Associate Director Regulatory Affairs 80-100%

What you will do
In this challenging and important role, you ensure and enforce worldwide Regulatory Compliance programs locally. You maintain and advance compliance at all Tecan facilities through implementation of global strategic regulatory affairs initiatives and through knowledge sharing and training. This role is focusing on the instrumentation business of Tecan.

Responsibilities will include

• Lead and support the development of regulatory product strategy, device and/or component knowledge, global and regional regulatory requirements and implementing these locally, including product classification strategies, assessments and conformity through to registration and achieve timely regulatory approvals
• Responsible for the maintenance of regulatory product strategy and its lifecycle management inclusive of post market surveillance, proactively identifying emerging issues that may impact development plans. Adjustment of the strategy and implementation plan in response to new information or changes. Responsible for interfacing with authorities and ensuring all vigilance and post market reporting is complete.
• Provide leadership and guidance to senior executives, peers and colleagues on product regulatory matters and develop cross-functional partnerships with internal and external stakeholders. Develop and conduct training as required on regulatory topics.
• Ensure efficient market surveillance and notification of internal departments of changed or new laws for implementation from North/South America, EU, Middle East, Africa and Asia Pacific
• Lead and develop the Regulatory Affairs Instrumentation team
• Review development, supply, quality, customer (Partnering Business), and distributor contracts as a part of the business processes and ensure mitigation of regulatory risks and compliance with corporate guidelines

What you bring along

• Degree in engineering, microbiology, chemistry, medical or other scientific discipline or equivalent experience
• RAPS Certification or other QARA specialized certificates is a plus
• 10+ working experience in a QA/RA role
• At lease 5 years of experience with an IVD product line
• Fluent English skills, German is beneficial
• Application of Medical Device and IVD/IVDR regulations globally
• Knowledge and application of FDA, China, EU IVDR , Rest of World Product Development standards, Medical Device and IVD regulations desired

What you will get

• Comprehensive Compensation and Benefits package
• Progressive employment conditions
• Exciting career opportunities
• Wide range of training courses
• International and diverse environment (30+ different nationalities)
• Strong company culture with rich history
• Global mindset with “Swissness” at heart
• Extremely attractive location overlooking the lake of Zurich

Look no further and apply now!

We are looking forward to receiving your application online. Please submit your resume (w/o picture and w/o cover letter, reference letters and diplomas are optional).

We will only consider applications that fully meet our requirements.