Director Regulatory Affairs
QIAGEN
Wroclaw, Poland
Position Description
- 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.
Position Requirements
- 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.
Personal Requirements
- 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.
Apply Now
Don't forget to mention EuroPharmaJobs when applying.