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Specialty Diagnostics Group:
Driven by our goal oriented team of service experts, the Microbiology Division (MBD) is a trusted supplier of a broad range of high quality media and diagnostic products used in clinical, industrial, research, and academic laboratories. For over 30 years, the group consisting of over 2,000 employees has been highly dedicated to microbiology and provided superior product performance and expert, responsive customer support to laboratories nationwide.
Brief Role Summary:
Thermo Fisher Scientific is seeking a Regulatory Affairs (RA) Leader to lead the RA team for Food safety testing products within the MicroBiology Division (MBD). This is a brand new role in the organization, to support our ambitions in food safety testing and we are looking for the person who is excited by the opportunity to shape, define and develop MBD’s understanding of the customer and industry expectations in this area. The main focus of this role is to develop and implement the regulatory affairs strategies required to introduce and maintain MBD’s food safety testing products in multinational markets. The Regulatory Affairs Leader – Food will report to the Global Director, Regulatory Affairs in MBD.
- Develop and deploy global regulatory strategies for new product development and mature products initiatives for the US & EU markets and manage the execution of regulatory strategies and processes to gain and maintain worldwide product clearances and in a timely manner.
- Lead the product RA team to develop and implement current regulatory requirements, practices and applicable QMS processes for assigned sites (presently Vantaa, FI & Lenexa, KS) to ensure ongoing regulatory compliance.
- Utilize regulatory intelligence and the metrics on pre-market licensure activity and feedback into the product development loop, to increase speed of pre-market clearance.
- Develop and maintain external relationships with global food safety agencies (government & third party) in all applicable territories.
- Develop forward looking intelligence that highlight 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 site Management Representative for Food Regulatory Affairs and support audits as needed.
- Graduate degree (or equivalent) in Science in the Biological or Agricultural Sciences, Engineering or Food Regulatory Affairs/legal field.
- 5-7 years of food regulatory experience in food safety product or related industry or within a government agency with food safety testing oversight
- 8-10 years of food regulatory experience in food safety product or related industry or within a government agency with food safety testing oversight
- Experience in strategic planning, collaboration and stakeholder management within a matrixed organization as well as government.
- Progressive & proven record of leadership with global product responsibility.
- High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction.
- Excellent communication and presentation skills.
- Adeptness in multinational regulatory strategy, risk-benefit analysis, collaboration with internal and external stakeholders, key opinion leaders and regulators.
- Project management skills (Work breakdown structure, basic Gantt charting, communication plan) to manage regulatory projects.
- Ability to develop and manage a high-performance team focused on accountability.
- Ability to lead, influence and innovate within a cross-functional environment.
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