Senior Manager, Regulatory Affairs

Job Description

Thermo Fisher Scientific Inc., a global leader in scientific solutions, highlights an annual revenue of approximately $40 billion. Our Mission is to contribute to a healthier, cleaner, and safer world. We are dedicated to supporting our customers, whether they are involved in life sciences research, solving complex analytical challenges, diagnostics, or the development of life-changing therapies. With a diverse workforce of over 130,000 professionals, we offer a wide array of innovative technologies, convenient procurement options, and pharmaceutical services through our renowned brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. Equivalent experience is accepted in place of specific educational requirements. For more information, please visit www.thermofisher.com.

How will you make an impact

We are looking for a highly motivated and experienced Senior Manager to join our Regulatory Affairs team within the Clinical Diagnostics Division. As Senior Manager, you will play an important role in developing and leading a world-class team that supports the diverse mix of diagnostic segments we serve.

You will be joining the Biomarkers, Automation, and Instrumentation (BAI) team, with locations in Finland, Germany, and France. The position involves regular travelling to these sites.

What will you do

• Develop and mentor regulatory staff to build a best-in-class global regulatory team.
• Lead, motivate and guide associates in a matrix organization on industry-leading practices.
• Attract and develop top talent to build an outstanding regulatory function.
• Advise the business unit regulatory teams on the optimal regulatory strategies, submissions, and approval pathways.
• Manage a complex and diverse set of registration/regulatory requirements across global markets to enable the product global registrations.
• Partner with R&D, marketing, operations, and business leadership for delivering on agreed timelines and global commercialization approaches.
• Create strong and proactive relationships with cross-functional functions.
• Lead interactions with Notified Bodies, FDA, & global regulatory authorities to gain alignment on regulatory strategies and resolve concerns to expedite approval of pending applications.
• Remain well-versed in evolving global regulatory policies and advise business units internally on anticipated changes, net business effect and develop appropriate strategies/processes to appropriately address.
• Coordinate regulatory communications with marketing to ensure appropriate approval of commercial literature and language.

How will you get here?

• Minimum 7+ years of regulatory affairs experience that includes interaction with regulatory bodies (Notified Body, FDA, global health authority interactions).
• Expertise in the EU and US markets is strongly desired.
• Equivalent experience in a scientific field will be considered in lieu of an undergraduate degree (B.Sc. or its equivalent). Advanced degree is preferred.
• Hands-on experience with classification of devices; listing, registration, and approval of devices required; adverse event reporting, and recalls desired.
• Experience interpreting and working under the regulations governing the approval of new products and the expectations and processes employed by the FDA and EU agencies, CE mark, 510k, PMA, EUA, technical files and design dossier. Additional experience with similar ex-US regulators (e.g. Japan PMDA, China NMPA, Brazil ANVISA, Health Canada etc.) ideal.
• Possess IVD technical expertise and regulatory knowledge to lead products through the approval and commercialization phases.
• Excellent communication and interpersonal skills.
• Ability to thrive in a matrixed organization and adopt diversity.

Please send in your application, including a cover letter, CV and salary request in English. Please apply via http://jobs.thermofisher.com/ by 9th of June 2024. Reference: R-01234882. Please apply as soon as possible, the position will be filled as soon as suitable candidate is found.

If you have questions about Thermo Fisher Scientific and/or the position - please contact Petra Norrman, Recruiter Nordics, petra.norrman@thermofisher.com.

About us:

Each one of our 130,000 extraordinary minds has a unique story to tell. It’s not just a career, it’s a chance to realise your best – professionally and personally.

Join us and contribute to our mission—enabling our customers to make the world healthier, cleaner and safer: http://jobs.thermofisher.com