Job Summary:
As a Senior Regulatory Affairs Manager, you will contribute to the Global Regulatory Affairs team by providing expertise in regulatory intelligence activities and product regulatory activities.
About This Role
This is a senior management position that requires strategic thinking and leadership skills. As a Senior Manager Regulatory Affairs, you will be responsible for communicating new or revised product-related information to global functions, leading regulatory affairs projects, reviewing promotional material, creating regulatory procedures, and giving regulatory advice.
Main Responsibilities
* Regulatory Intelligence: Communicate new or revised product-related information to global functions (QARA, business, R&D, operations, etc.) about applicable international standards, regulations, and laws.
* Project Leadership: Lead regulatory affairs global projects due to regulatory landscape changes and influence internal company stakeholders and delegates as necessary.
* Review and Compliance: Review Advertising, Promotional, and Labelling material and interact strategically with Marketing counterpart to ensure timely and accurate regulatory reviews.
* Procedure Development: Create or revise and implement regulatory procedures, ensuring regulatory policies are maintained.
* Regulatory Advice: Give regulatory advice consistent with Tecan global regulatory affairs policies for the area of responsibility.
* Strategic Development: Lead the development of Global RA strategies with the RA team and implement those strategies as assigned to ensure ongoing compliance.
* Product Strategy: Independently prepare product regulatory strategies and assessments for internal project development teams or upon request that are compliant with global regulations.
About You
* Education: Degree in scientific discipline, engineering, or equivalent experience (RAC certification or other professional certification preferred).
* Experience: Minimum 8 years of experience in Regulatory Affairs, with 1-3 years of people management experience.
* Industry Knowledge: Experience in the Medical Device or IVD industry, with IVDR/MDR knowledge.
* Perspective: Self-motivated, pragmatic, and solution-oriented.
* Skills: Able to work independently, approachable, informative, and respectful in dealing with internal employees, customers, and partners.
* Language Skills: Fluent in English; German would be an asset.
What We Offer
* Culture: Working in an international and diverse environment.
* Growth Opportunities: The chance to grow your career within the company.
* Empowerment: Feel empowered by our strong and unique company culture.
* Compensation and Benefits: Comprehensive compensation and benefits package.
Our Purpose
We are driven to improve people's lives and health by empowering our customers to scale healthcare innovation globally from life science to the clinic.
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.