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 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 and Patheon. For more information, please visit www.thermofisher.com. 

 
Senior Manager, Regulatory Affairs
Job location: Flexible (Europe or US East Coast)
 
The job:
 
Working as part of our Microbiology Division (MBD), within the Specialty Diagnostics Group, you’ll play an active part in helping us to achieve our mission to enable our customers to make the world healthier, cleaner and safer. The Microbiology Division discovers microbiological solutions for the diagnosis of infectious disease and the detection of bacterial contamination.  We serve public health, clinical laboratories, food companies, environmental screening and pharmaceutical laboratories with a portfolio of products that include culture media, antimicrobial susceptibility testing solutions and market-leading molecular solutions for food safety testing.
 
This is a divisional role in MicroBiology Division’s (MBD) Global Regulatory Affairs (RA) function leading the RA function for the assigned product groups – Mass Spectrometry & Media. The primary purpose of this role is to lead the RA team in development and deployment of global RA strategies for new & existing products in MBD’s mass spectrometry and Media range and maintain compliance to applicable IVD regulations. The main interfaces for this role include R&D, Product Management, QA, regulators for pre-market activities, and MBD Market Access & Operations RA
 
 
What will you do?
 

• Own the Regulatory Affairs leadership of the Media and Mass Spectrometry product ranges as well as provide regulatory support for onsite activities at Vantaa FL, Basingstoke UK, Lenexa USA, Perth UK, Wesel DE, Melaka MY, Beijing CN, Adelaide AU, Jo’berg SA, Ottawa CA
• Develop and deploy global regulatory strategies for new product development and mature products initiatives globally
• Manage the RA professionals aligned to the product group providing full life-cycle support of new and mature products in the product group
• Developing a high performing team and maintaining team capability relative to the Animal By-Products regulation and other applicable product regulations
• Owning the QMS processes and intersections for responsibilities related to the regulatory functions at each site supported e.g. Change Control, CAPA, etc. Develop, implement and maintain rich QMS processes
• Work collaboratively with Market Access RA to gain and maintain market access globally for the product group
• Develop and maintain external relationships with key Pre-Market regulatory officials in all applicable territories
• Develop forward-looking intelligence that highlights significant changes to global regulations impacting the product group and implement the required changes to ensure we are positioned to remain compliant.
• Perform regulatory review and approval of labelling and Ad/promo materials
• Act as Management Representative for Regulatory Affairs and support audits
• Participate in and lead functional initiatives within the division

• Successfully proven experience in developing and implementing multinational RA strategies for Medical devices/ IVDs (including US, EU, China and emerging markets) for breakthrough and legacy products
• Thrives in strategic planning, collaboration and stakeholder management within a matrixed organization
• Nuanced regulatory knowledge communicated clearly
• An experienced and inspirational leader

 
 
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.
 
Apply today! 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.
 
 
About us:
 
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 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 and Patheon
 
With Thermo Fisher Scientic, it’s not just a career.  It’s a chance to realise your best – professionally and personally.
 
Apply today!
 
http://jobs.thermofisher.com