Job Title: Regulatory Affairs Specialist
Job Location: East Grinstead / Dartford
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.
Brief role summary:
Thermo Fisher Scientific is seeking an experienced Regulatory Affairs professional to assist with the maintenance of current product registrations, define and implement regulatory strategy for new products and to ensure continuing regulatory compliance. The Regulatory Affairs Specialist will report to the Regulatory Affairs Manager (ID, AST & Instrumentation).
- Develop and implement regulatory strategy across projects to ensure that company products are safe, legal and meet expectations for compliance with national and global regulations
- Maintain and improve upon processes to ensure compliance with required regulatory standards and governing bodies
- Generate records and documentation for inclusion into Technical Files and global regulatory submissions
- Monitor and maintain government regulatory registration databases
- Represent the Regulatory Affairs function at multi-departmental meetings
- Liaise with competent authorities and notified bodies to seek advice and guidance when necessary.
- Degree in Life Sciences or Engineering
- Significant experience within the IVD or medical device industry
- Excellent IT skills
- Knowledge of IVD Directive (98/79/EC) and US 510(k) submission process
- Experience of working with active devices (IEC 60601, IEC 61010, IEC 62304)
- Excellent attention to detail
- Ability to plan multiple tasks and effectively prioritize activities
- Effective communicator with management, peers and internal customers
- Capability to drive assignments to completion
- Good planning and organizational abilities
- Pro-active with proven ability to work under own initiative, and strong team player
- Current full Driving License.
At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com