Medical Device, Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs
- 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.
Minimum 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.
Internal Number: 8359
As the innovative market and technology leader, QIAGEN creates Sample to Insight solutions that enable access to valuable molecular insights from any biological sample.
Our mission is to make improvements in life possible by enabling our customers to achieve outstanding success and breakthroughs in life sciences, applied testing, pharma and molecular diagnostics.
Our commitment to the markets, customers and patients we serve drives our innovation and leadership in all areas where our Sample to Insight solutions are required.
The exceptional talent, skill and passion of our employees are key to QIAGEN´s excellence, success and value.