Ever wondered how your skills and unique background could impact the world of tomorrow? Join our Global Regulatory Affairs team and bring your passion and talent to work.
Senior Regulatory Affairs Manager
Männedorf, Switzerland
Your contribution
As Senior Manager Regulatory Affairs you will contribute to the Global Regulatory Affairs team by providing expertise in both regulatory intelligence activities through monitoring the global regulatory landscape and working with Tecan stakeholders to implement and product regulatory activities (strategies, life-cycle management, compliance and registrations).
Responsibilities
- Communicates and alerts global functions (QARA, business, R&D, operations etc.) about new or revised product related information such as applicable international standards, regulations and law.
- Leads regulatory affairs global projects due to regulatory landscape changes and influences internal company stakeholders and delegates to team as necessary.
- Reviews Advertising, Promotional, and Labelling material, interacts strategically with Marketing counterpart to ensure timely and accuracy regulatory reviews.
- Creates or revises and implements regulatory procedures, ensures regulatory policies are maintained.
- Give regulatory advice consistent with Tecan global regulatory affairs policies for area of responsibility.
- Leads development of Global RA strategies with RA team and to implement those strategies as assigned and ensure ongoing compliance.
- Independently prepares product regulatory strategies and assessments for internal project development teams or upon request that are compliant with global regulations.
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Your background
We’re not just looking for hard skills: We’re looking for people who bring their passion and talent to work.
- Degree in scientific discipline, engineering or equivalent experience (RAC certification or other professional certification preferred)
- Minimum 8 years experience in Regulatory Affairs, 1-3 years people management experience
- Experience in Medical Device or IVD industry, IVDR/MDR knowledge
- Self-Motivated, pragmatic and solution orientated
- Able to work independently
- Must be approachable, informing, and respectful in dealing with internal employees, Tecan’s customers and partners
- Fluent in English; German would be an asset.
What makes working at Tecan unique
The chance to make it count and to have an impact on the world of tomorrow
- Working in an international and diverse environment
- The chance to grow your career within the company
- Feel empowered by our strong and unique company culture
- Comprehensive compensation and benefits package
Join Tecan, a great place to work! Read about our recent certification from Great Place to Work.
We’re looking forward to receiving your application online. Please submit your CV or resume (w/o picture and w/o cover letter, reference letters and diplomas are optional).
Our purpose.
At Tecan we are driven to improve people’s lives and health. We do this by empowering our customers to scale healthcare innovation globally from life science to the clinic. We collaborate with our customers from early-stage innovation through project implementation and beyond. We deliver the products, services and solutions that make lab processes and medical procedures precise, reproducible and compliant.
Stay unique and make it count.
Our values - trust, highest standards and ambition - are the cornerstones of our business and provide the framework for Tecan's culture. We foster a positive and empowering environment where our rarest assets, our unique employees, can grow and bring their passion and talent to work.