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Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 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, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 130,000 colleagues delivers an unrivaled 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, Patheon and PPD. For more information, please visit www.thermofisher.com .

About Finland

Our Finland locations include Vantaa and Joensuu, employing over 800 professionals in R&D, production, supply chain, quality, marketing, sales, and administrative support. We hire experts in different fields including engineering, chemistry, microbiology, and bioinformatics. Our Vantaa site develops laboratory automation solutions, clinical chemistry and industrial chemistry analyzers and assays, food safety kits, pipettes and other diagnostics and research solutions. It is conveniently located close to the Vantaankoski railway station. Please read more about Finnish sites, innovative work, and collaborative colleagues at https://jobs.thermofisher.com/global/en/finland .

How will you make an impact?

As Senior Manager, Regulatory Affairs you will be responsible for developing a multi-faceted and high-functioning Regulatory Affairs team within the Thermo Fisher Scientific, Clinical Diagnostics Divisional level. The Clinical Diagnostics Division (CDD) is an organization made up of business units which develop, manufacture and market instruments and consumables that serve a broad, diverse mix of diagnostic segments. The major business units include Niche Diagnostics, Biomarkers Automation / Instrumentation, and Clinical Diagnostic Reagents. This position will be in the Biomarkers, Automation, and Instrumentation (BAI) team, with locations in Finland, Germany, and France.

This Senior Manager will be experienced with successful IVD product submissions, globally. Expertise in writing IVD Submissions, in particular for the US and EU strongly desired. Experience with software and instruments strongly desired.

You will report to the Senior Director of Regulatory Affairs, CDD. The Senior Manager will participate in regulatory strategy development and its implementation, including formulation of strategies for new products and markets. We will work together to implement a best in class Regulatory team that meets the needs of our diverse mix of diagnostic segments!

What will you do?

• Develop regulatory staff to build a best-in-class global regulatory team. Lead, motivate and guide associates in a matrix organization on industry-leading practices. Attracts and develops 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.

• Oversee 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)

• Particular expertise in the EU and US markets is strongly desired.

• Undergraduate degree (B.Sc. (or equivalent)) in scientific field required; advanced degree 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.

• Experienced in direct, professional, regulatory interactions with customers and OEM business partners.

• Technically savvy using IT databases and familiarity with commercial digital tools desired.

• Ability to get results in a matrixed organization, especially having representatives from different cultures come together, embracing diversity.

In addition to the interesting and versatile job, we offer:

• Compensation on various methods from annual bonus scheme to colleague recognition program

• Variety of occupational health care services and insurance

• Possibility to work remote with agile and mobile working methods

• Epassi leisure benefit

• Various hobby clubs with company sponsorship such as golf club, boating club, sport club etc.

• Possibility to take part in our charity work

• Career development and progression possibilities offered by our global network

• Our comprehensive training platform and programs

• Be part of our mission to enable our customers to make the world healthier, cleaner and safer

Please send in your application, including a cover letter, CV and salary request in English. Please apply via http://jobs.thermofisher.com/ by 5th of May 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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.