Senior Regulatory Affairs Manager
Vor 3 Tagen
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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
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 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 the team as necessary.
- Reviews Advertising, Promotional, and Labelling material, interacts strategically with Marketing counterpart to ensure timely and accurate regulatory reviews.
- Creates or revises and implements regulatory procedures, ensuring regulatory policies are maintained.
- Gives regulatory advice consistent with Tecan global regulatory affairs policies for the area of responsibility.
- Leads the development of Global RA strategies with the RA team and implements those strategies as assigned to ensure ongoing compliance.
- Independently prepares product regulatory strategies and assessments for internal project development teams or upon request that are compliant with global regulations.
Your background
- Degree in scientific discipline, engineering, or equivalent experience (RAC certification or other professional certification preferred).
- Minimum 8 years of experience in Regulatory Affairs, with 1-3 years of people management experience.
- Experience in the Medical Device or IVD industry, with IVDR/MDR knowledge.
- Self-motivated, pragmatic, and solution-oriented.
- Able to work independently.
- Must be approachable, informative, 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
- 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 (without picture and without 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.
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