About the role
We are seeking a highly motivated and experienced Senior Compliance Engineer to lead and support hardware and reagent compliance initiatives across global regulatory frameworks. In this role, you will be responsible for interpreting and implementing regulatory requirements, managing product certifications, and ensuring compliance with standards such as UL, CE, FCC, RoHS, REACH, and other international directives. You will collaborate closely with cross-functional teams—including engineering, manufacturing, supply chain, and regulatory affairs—to ensure that all hardware and reagent products meet applicable compliance standards throughout their lifecycle. This position is critical to enabling successful product launches and sustaining market access across key global regions.
What you will be doing:
Hardware Product Compliance:
- Collaborating with a cross-functional team to ensure compliance to regulatory requirements including UL, CSA, FCC, CE, KCC, SRRC, PSE, CB.
- Submitting official certification through relevant compliance bodies such as FCC, CE, UL, TUV, KCC, MIC, SRRC, etc. and acting as a liaison between 10x Genomics and state, local, federal and international agencies to submit required forms and paperwork while maintaining date and files for future reference, particularly in the event of an audit by a regulatory agency.
- 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.
- Determining and interpreting the relevant regulatory standards such as IEC 61010-1, IEC 61010-2-010, IEC 61010-2-081, IEC 60601 and how they apply to 10x Genomics products to establish and maintain guidelines and best design practices to mitigate compliance issues early in the design phase.
- 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.
- Maintaining a deep understanding of new and existing regulation that may impact 10x Genomics products and processes and using that understanding to standardize all business operations and establish clearly documented protocols while explaining regulations, procedures and policies to all employees and stakeholders as necessary.
- 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 Requirements:
- 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.
