Job Title: Regulatory Affairs Specialist, Product Environmental Regulations
Position Location: Preferred location Dartford UK (alternatively Basingstoke or East Grinstead)
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.
The Regulatory Affairs Specialist, Product Environmental Regulations will be responsible for co-ordinating Product Compliance activities with respect to environmental legislation impacting on all products within the Microbiology Division. The Regulatory Affairs Specialist, Product Environmental Regulations will establish all necessary procedures, processes and systems to ensure all products meet the global environmental compliance requirements in the markets where they are placed.
The Regulatory Affairs Specialist, Product Environmental Regulations will develop, maintain and execute tactical plans to support Company policies and product compliance strategies. Additionally, the Regulatory Affairs Specialist, Product Environmental Regulations will participate in corporate and divisional working groups relating to Product Environmental Compliance initiatives and objectives.
- Maintain awareness and understand operational impact of all relevant international product environmental compliance requirements.
- Ensuring compliance with all relevant environmental regulations, directives and legislation affecting Microbiology Division products.
- Establish and maintain all Standard Operating Procedures and/or Work Instructions relative to the function.
- Participate in all new product design and launch reviews.
- Conduct compliance assessments for new and existing products, including hazard assessment/SDS authoring, labeling requirement, and support chemical notifications,registrations and market restrictions
- Develop and maintain standards for instrument safety (e.g. LVD, EMC, Machinery, RID, etc), marking (e.g. CE, NRTL) and Material Declaration.
- Support site EHS personnel where product safety information impacts industrial hygiene and environmental emission responsibilities.
- Support trade compliance teams to provide necessary documentation and certifications for Import/Export of products and raw materials
- Represent Microbiology Division in relevant internal/external audits and interact with federal/national, state, local and international agencies governing product regulations and laws.
- Establish/Maintain all product compliance KPIs
- BSc degree in Biochemistry/Chemistry, Engineering, Environmental Sciences or related subject.
- Significant experience in a product compliance role in a related industry or chemical manufacturing operation.
- Proven knowledge of European product compliance regulations and directives (e.g. REACH, RoHS, CLP, Biocidal Products,etc.). Knowledge of international product compliance laws (e.g. TSCA, HazComm 2012, K-REACH, MEP-7,, etc.) is preferred
- Ability to analyze and interpret product focused legislation and determine their applicability to company operations and products.
- Ability to effectively present information in written and oral form
- Ability to manage multiple large-scale projects concurrently.
- Some domestic/international travel (<10% of time)
- Critical Thinker
- Greets challenge and change as opportunity
- Anticipates needs and problems while creating solutions
- Customer centric
- Bench level experience in R&D, Process Development or Manufacturing
- Experience with REACH-IT tools, including IUCLID and Chesar
- Ability to thrive in an environment without on-site supervision while taking initiative and subject leadership in areas of direct responsibility.
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