Product Compliance SpecialistVerified as a real position
Thermo Fisher Scientific
Czechia, Brno2 weeks ago
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ComplianceSeniorCE complianceRegulační rámceElektrotechnikaFSE certifikace výhodouSamostatnostAngličtina
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Who we’re looking for
- Bachelor's degree in electrical engineering or equivalent technical qualification combined with relevant professional experience
- Deep understanding of regulatory frameworks including EN 61010, EN 60601, Low Voltage Directive, Machinery Regulation, and IVD Regulation
- Functional Safety Engineer certification (preferred)
- CE representative certification (preferred)
- Proven ability to manage competing priorities and deliver results in fast-paced environments
- Exceptional communication and collaboration skills with the ability to influence across teams and cultures
- Self-directed work approach with strong analytical and problem-solving capabilities
- Skilled at interpreting complex technical standards and translating them into actionable requirements
- Fluent English communication skills; additional languages are a plus
- Willingness to travel up to 20 % as needed
What you’ll do
- Drive compliance excellence across all AAT (GC/GCMS/TEA) development and product modification projects through: Researching and interpreting current standards and regulations to ensure CE, NRTL, and other required compliances
- Designing and executing comprehensive internal and external testing strategies to meet regulatory requirements
- Managing third-party testing partnerships and implementing corrective actions
- Evaluating deviations and their impact on project timelines and product development outcomes
- Serve as CE representative for AAT Business Unit devices, creating and maintaining technical product documentation (e.g., CE Technical Files)
- Champion process optimization initiatives to strengthen compliance in development and production workflows
- Proactively monitor and implement updates to evolving standards, regulations, and directives
- Act as the go-to expert for compliance guidance throughout the AAT product lifecycle
- Collaborate cross-functionally with compliance specialists and quality teams across divisions
- Lead compliance coordination efforts across multiple Thermo Fisher AAT sites globally
- Leverage emerging technologies, including AI-driven tools, to enhance compliance workflows and documentation accuracy
About the position
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Benefits
- This position offers opportunities for professional growth and development in an innovative organization committed to integrity and excellence.
- You'll make meaningful contributions to facilitating global trade while ensuring regulatory compliance and managing risk.
