Job Title: Director, Regulatory Affairs – EMEA Region
Location: Europe - Remote
How will you make an impact?
The Director of Regulatory Affairs for the EMEA region will be responsible for the Genetic Sciences Division (GSD), driving regulatory and clinical strategies to support the business. The incumbent will be part of the Thermo Fisher Scientific GSD Quality and Regulatory team and based in EMEA, serving as an active leader of Regulatory Affairs supporting the growing GSD businesses.
What will you do?
GSD focuses on various diagnostics solutions including test kits, reagents, instruments, software and associated products. Our products empower healthcare providers to make medical decisions, faster, more accurately and more cost effectively for patients. What we do matters because our work has a direct impact on people’s lives, and we take that responsibility seriously. The Director, Regulatory Affairs EMEA Region is responsible for leading the activities of the regulatory team with emphasis on regulatory strategy and the preparation, review and submission of documents for product submissions within the region. The Director of Regulatory Affairs will combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet all required legislation. The leader will develop, mentor, and supervise regulatory professionals within EMEA.
Other duties include:
- Regulatory lead for the EMEA region. Partners with business leads to develop regulatory strategy to align with business strategy within the region for all regulated product within the GSD portfolio.
- Responsible for providing regulatory guidance and support to product development teams for strategic planning, design and development, and post-market surveillance and compliance activities within the region.
- Writes, coordinates, compiles, and submits Regulatory documents to support product registrations to regional Regulatory Agencies, including Europe, Eastern Europe, Middle Eastern countries, South Africa, and India
- Engages regulators, when necessary, in oral and written communications to discuss pending or new submissions, regulatory requirements, address questions etc.
- Services as RA subject matter expert and keeps up to date with EU and other regional regulations.
- Coordinates regulatory issue resolution using internal resources, regulatory agencies, and outside consultants as needed.
- Conduct trainings and/or communicate appropriate materials, as needed, in order to enhance team’s knowledge of working in a regulated environment.
- Reviews and approves proposed labelling, packaging, advertising and promotional materials after evaluating conformance to regulations
- Participate in business meetings with existing and prospective external partners.
- Manages team of regional regulatory professionals.
How will you get there?
- Extensive regulatory experience in Medical Devices and a minimum of 5-7 years of IVD (InVitro Diagnostics) experience.
- Demonstrated experience in multiple aspects of regulatory affairs, including; strategy creation, design control, cGMP/Quality Systems, and import/export requirements.
- Experience representing RA on project core teams providing active and successful regulatory guidance and RA strategy.
- Successful experience in communicating with Regulatory Agencies.
- Customer facing experience.
- Minimum requirement of a Bachelor’s degree in life sciences, bio-engineering or related science. RAC certification from RAPS or another recognized institute is preferred.
- Strategic, Collaborative, and Decisive leader
- Existing relationships with global regulators
- Excellent written and verbal communication skills, including presentation skills. Demonstrated ability to communicate clearly, succinctly, and effectively.
- Comfortable communicating with executive management.
- Ability to work as a member of a team in a timeline-driven environment with limited supervision.
- Must possess strong organizational skills. Detail-oriented, yet able to handle multiple projects concurrently.
- Must be able to operate in a highly matrixed organizational construct.
About Thermo Fisher Scientific:
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivalled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com