When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation.  With revenues of $24 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world. 

Regulatory Affairs Manager

What will you do:

The Regulatory Manager is responsible for defining and executing regulatory strategy in line with Corporate and Divisional objectives and providing regulatory guidance to ensure Business compliance.
The Regulatory Manager is the front-line manager of a team of Specialists and Supervisor.

Main duties:

• Writes, coordinates, compiles, and submits Regulatory documents, including CE-IVD Technical Files, to Regulatory Agencies, including International Authorities.
• 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 current in regard to Directives and Regulations and guidance documents that pertain to any country of EMEA region.
• Reviews and approves internal and external communication, product documentation and any customer-facing document after evaluating conformance to regulations.
• Coordinates regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed.
• Partners with all applicable functions and distributors to ensure compliance and enable successful business.
• Participate in business meetings with existing and prospective external partners.
• Conducts trainings and/or communicate appropriate materials, as needed, in order to enhance team’s knowledge of working in a regulated environment.
• Mentor the direct reports, develop individuals and retain talents.
• Manage team of 5 regulatory professionals and provide oversight and guidance on regulatory strategies, submissions, and projects.

REQUIREMENTS / EDUCATION:

• Minimum of 5 years of IVD Regulatory Affairs experience. This experience must include CE-IVD experience and experience with National procedures in multiple countries.
• Demonstrated experience in multiple aspects of regulatory affairs, including; strategy creation, design control, change control (including technical transfer), cGMP/Quality Systems, and import/export requirements.
• Experience in 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​

• At Thermo Fisher Scientific, each one of our 70,000  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