Director Regulatory Affairs

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QIAGEN

Direct global in vitro diagnostic (IVD) and Life Science (LS) product strategies for development, submissions, registrations, and maintenance in global APAC, LATAM and EMEA regions.
Manage and further develop the Regulatory Management System (TrackWise)
Head the Global RA Datacenter for support of global product registrations including resource planning and development
Research and interpret global regulations, guidelines and precedents to support international registrations.
Direct solutions for complex topics regarding country specific regulations, guidelines, and precedents.
Develop Regulatory Affairs processes and procedures for the global organization.
Support other QIAGEN functions with product issues involving Regulatory Affairs aspects and collaborate with development teams on international regulatory matters.
Lead and or participate in communications, and meetings, with Regulatory Authorities and in-country representatives.

The ideal candidate will have 6-8 years of experience in regulatory affairs or other similar business sector, including leadership experience.
Extensive knowledge of requirements and processes for global regulatory approval of IVD medical devices will be beneficial
Knowledge of APAC, LATAM and EMEA regulatory requirements will be beneficial.
Proven track record of success in problem solving and developing risk-based solutions in dealing with global markets.
Understanding of global regulatory, government affairs, and mitigation legal liability issues.
Experience in managing international teams. Ability to travel and work internationally as needed.
Ability to manage Regulatory Information Management System.
Advanced degree preferred. RAC preferred.
Excellent verbal and written communications skills and the ability to convey complex requirements in a straightforward and practical manner.

Passionate leader, enthusiastic and able to inspire others to drive results while helping members at all sites feel competent, challenged, and supported a strong sense of ethics and a commitment to uncompromising integrity.
Ability to work well cross-functionally, and in team settings and independently, take a stand and ensure completion of time-critical projects.
Strategic thinker, with ability to find novel solutions to complex business challenges.
Structured and well organized.

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