Manage IVD product strategies for submission, registrations and maintenance, globally.
- Represent Regulatory Affairs on interdepartmental teams for projects with Operations, Development and other functions as required.
- Leads communications and meetings with Regulatory Authorities on behalf of Regulatory Affairs leadership.
- Support other QIAGEN functions in customer facing issues involving Regulatory Affairs aspects.
- Bachelor’s Degree
- At least 5-8 years of relevant professional experience required.
- Extensive knowledge of requirements and processes for approval of in vitro diagnostic medical devices, including companion diagnostics.
- Should be knowledgeable in next generation sequencing methodology.
- Good skills in standard PC software.
- Good language skills in English.
- Good verbal/written communication skills, especially for teleconferences.
- Limited travel expected.
QIAGEN is known to more than 500,000 customers around the world for our innovation, engagement, integrity, quality and passion. This identity creates relationships for our global team across the continuum from research in the life sciences, to molecular diagnostics and public safety applications in everyday use.Our mission is to deliver Sample to Insight solutions enabling QIAGEN customers to unlock valuable molecular insights faster, better and more efficiently – from the raw biological sample to the final interpreted result. But Sample to Insight is more than just about providing smooth, end-to-end workflows. It's a strategic framework that puts the needs and challenges of our customers front and center. We want to identify key bottlenecks holding customers back and to deliver solutions so they can achieve greater success, ultimately helping them to exceed their own expectations.