Collaborating with a cross-functional team to ensure compliance to regulatory requirements including UL, CSA, FCC, CE, KCC, SRRC, PSE, CB. Understanding RoHS, REACH, TSCA, Waste Electrical and Electronic Equipment Regulation and ensuring that new and existing products are designed to comply with those guidelines and tested accordingly. Ensuring compliance with global EMC and EMI regulatory requirements, and working closely with electrical and systems engineering teams to define and implement design guidelines for shielding, grounding, and layout strategies to reduce emissions and improve immunity. Staying up to date with any changes to global agency approvals and testing procedures, as well as reviewing marketing, legal and technical documentation (for example: labeling user guides and declaration of conformity) to assess compliance with regularly reporting on compliance status and measures to both internal and external parties. Preparing Manufacturing site ready for the Regulatory Body audit for Product Safety Certification. Establishing a routine manufacturing test equipment Program for Hipot & Ground Bond testing, and managing bi-annual audits with external regulatory agencies for Product Safety Certification. Minimum of Bachelor's degree in Electrical Engineering or related engineering field Given the complexity and narrow scope of business requirements, we also require Senior Regulatory Compliance Engineer, to have several years of experience and expertise in electrical engineering processes and procedures 10+ years of experience in regulatory compliance for hardware products, reagents, or both--preferably within the life sciences, diagnostics, or medical device industries Additional Experience with chemical and reagent compliance, including SDS authoring, GHS/CLP labeling, and familiarity with REACH, TSCA, and international chemical inventory regulations is strongly preferred Familiarity with environmental regulations (RoHS, REACH, WEEE, TSCA, etc.) and how they apply to product design, component selection, and global distribution Strong project management skills, with the ability to manage multiple regulatory timelines and interact with cross-functional teams (e.g., R&D, manufacturing, supply chain) Excellent technical writing and documentation skills, including experience with compliance reports, regulatory submissions, and audit-ready file maintenance Ability to interpret regulatory language and apply it practically to product development and compliance strategies Experience with software coding is an added advantage.
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