Place of work
As the world’s leader in serving science, Thermo Fisher Scientific is a driving force in the research, healthcare, industrial and applied markets, generating more than USD 20 billion in annual revenue. No other company can match our range of customer touch points – technologically, geographically or commercially. We help our customers in finding cures for cancer, protecting the environment, making sure our food is safe and moving forward with thousands of important projects that improve millions of lives.
At Thermo Fisher Scientific, each one of our 65,000 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.
Regulatory Compliance Engineer
Thermo Fisher Scientific
Who we are/ what we do
Regulatory Compliance is a multi-disciplined, international team that encourages free thinking, with objective input and expertise in quality systems, business process excellence, structured problem solving, Environmental Health & Safety and regulatory compliance.
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 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.
- Program manage all necessary worldwide electrotechnical documentation, testing, declarations and certifications for multiple product lines
- Manage product documentation, labeling and retail packaging updates resulting from regulatory requirement changes
- Work closely with global cross functional groups including R&D, product planning, marketing, global subsidiaries, legal and localization services to ensure that our products meet global regulatory requirements.
- Evaluate and interpret World-Wide regulations and standards, guiding design teams to ensure compliant end-product solutions are achieved.
- Perform product design reviews to ensure proposed solutions are compliant with applicable safety /product regulatory requirements in targeted markets.
- Serve as a product liaison for all Regulatory activities for both internal and external suppliers, customers and stakeholders.
- Awareness of and basic understanding of chemical systems, fluid and gas delivery, chemical safety, global chemical restriction and chemical control laws, Industrial Hygiene
- Ability to understand and troubleshoot complex technical and regulatory problems, consult with relevant stakeholders, and propose practical solutions
- Knowledge of industry standards/regulations that impact electronics products, labeling requirements; CE marking directives - EU Machinery, Low Voltage, EMC, Pressure Equipment, RoHS Directives; IEC/EN/UL Standards e.g. IEC 60204, UL61010A, etc.; Product-related laser standards & requirements – ANSI Z136, FDA-CDRH & IEC 60825; EU & country specific chemical, REACH, RoHS, WEEE and Prop65.
- Ability to apply hazard/risk analysis, to identify compliance deficiencies, opportunities to improve product safety and/or quality; effectively document, communicate and track results to resolution
- Create and execute regulatory test plans, include required standards, test specifications, estimated cost, turn-around time and submittal strategy for targeted markets.
- Track and report on regulation changes and trends
- Employ known or forward thinking techniques to aide site management in problem solving.
- Be a technical resource to guide site management in their responsibilities for Regulatory Compliance addressing, electrical, mechanical, chemical safety and radiation safety.
- Address Environmental, Health and Safety issues raised via the CAPA process.
- Participate in audits conducted by regulatory agencies, customers and internal auditors.
- Be hands-on and ready to roll up the sleeves to fill in where required in meeting the site or departmental objectives.
- 5 years’ experience in hardware compliance certifications work, with a track record of effectively managing a program in a global, empowered, and changing environment
- 1+ years’ experience and understanding of international regulatory requirements such as Electromagnetic Compatibility, RF, energy efficiency
- Applicable knowledge of how to perform hazard/risk analysis – FMEA a plus.
- Strong program management, time management, prioritization and organizational skills
- Excellent written and verbal communication skills required. Must be able to communicate effectively in English and Czech – other languages are a plus.
- Regulatory experience working in an ISO 9001/14001 environment.
- A demonstrated working knowledge of CE standards and directives, e.g., Machinery directive, EMC directive, Various Product Safety standards, as well as a strong familiarity of EURATOM Ionizing Radiation Directive and Pressure Equipment Directive, SEMI and NFPA-79 standards
- Experience working in high-tech environment, and specifically capital equipment.
- Bachelor’s engineering degree or equivalent experience in a technical/scientific field.
- Strong computer and technical skills, data analysis and reporting using Microsoft Excel and Word. MS Access, PowerPoint, Project and SharePoint is a plus.
- Must have a valid passport and able to travel domestically/internationally ≤10% of the time.
- Must be an effective and persuasive communicator with the ability to effectively convey ideas to all levels of management.
- Skilled problem solver who works with a sense of urgency and is results oriented.
- Must be self-motivated, with key strengths in initiative, dependability and teamwork.