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.
Regulatory Compliance is a multi-disciplined team where each member is expected to provide objective input and expertise in quality systems, business process excellence, structured problem solving, regulatory compliance and environmental health. We support our brand with regard to fulfilling customer needs, compliance to legislation and industry requirements and helping the organization to quantify and define what quality, compliance, and safety is to Perfect Quality System Health, Perfect Design, Perfect Order and Perfect Service, by monitoring and driving improvements through a structured operating rhythm.
The Product Safety Compliance Engineer will be responsible for coordinating Product Compliance activities for his/her site and or division. He/she will establish all necessary procedures, processes and systems to ensure all products meet the global product safety compliance requirements in the markets where they are placed. He/she will develop, maintain and execute tactical plans to support Company Regulatory Compliance policies.
Maintain site and divisional awareness of the operational impact of all relevant international product & environmental compliance requirements as they pertain to products.
Assures compliance with applicable internal and external regulations, policies and procedures related to product safety. Participate in all new product design and launch reviews to ensure product safety and compliance. Will be relatively autonomous, with the authority to make relevant decisions regarding all aspects of products safety and compliance matters for the site. Represent Business in relevant internal/external audits and interact with federal/national, state, local and international agencies governing product regulations and laws.
The successful candidate for this position will possess the following combination of education and experience:
A bachelor’s degree in engineering, electronics is preferred, is required, or a combination of education and experience that demonstrate the required skills.
~ 5-10 years of relevant working experience in product safety / product regulatory.
Proven experience to judge engineering solutions and their impact in product safety, mechanics, EMC, electrical & electronic, chemical, X-ray, pressure vessel and publications.
A demonstrated working knowledge of CE directives: Machinery directive, EMC directive, EURATOM Ionizing Radiation Directive and Pressure Equipment Directive. Thorough understanding of the IEC 61010-1 standard with proven expertise in evaluating and testing products against the specified design requirements.
Able to work independently, be a self-starter.
Experience working in high-tech environment, and specifically capital equipment.
Excellent interpersonal and communications skills with the ability to interact effectively with others, which includes senior and middle management levels. And to translate the safety and regulatory requirements into design requirements for R&D engineers which don’t have the product safety and regulatory knowledge.