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. Must be able to work onsite in Pleasanton CA
What you will be doing:
- 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 (WEEE) 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.
- Partner with R&D to ensure 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
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About 10x Genomics
At 10x Genomics, accelerating our understanding of biology is more than a mission for us. It is a commitment. This is the century of biology, and the breakthroughs we make now have the potential to change the world.
We enable scientists to advance their research, allowing them to address scientific questions they did not even know they could ask. Our tools have enabled fundamental discoveries across biology including cancer, immunology, and neuroscience.
Our teams are empowered and encouraged to follow their passions, pursue new ideas, and perform at their best in an inclusive and dynamic environment. We know that behind every scientific breakthrough, there is a deep infrastructure of talented people driving the life sciences industry and making it possible for scientists and clinicians to make new strides. We are dedicated to finding the very best person for every aspect of our work because the innovations and discoveries that we enable together will lead to better technologies, better treatments, and a better future. Find out how you can make a 10x difference.
Individuals seeking employment at 10x Genomics are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation, or any other characteristic protected by applicable law.
10x does not accept unsolicited applicants submitted by third-party recruiters or agencies. Any resume or application submitted to 10x without a vendor agreement in place will be considered unsolicited and property of 10x, and 10x will not pay a placement fee.
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What We Do
Accelerating biological understanding and discovery is more than a mission for 10x Genomics. It’s a commitment. Fueled by equal parts scientific vision and determined passion, we are enabling fundamental research across the life sciences by delivering rapid innovation that allows our customers to resolve complex biology—across the fields of oncology, immunology, neuroscience, and more.
As we deliver powerful new methods for discovery, we create opportunities for scientists to address and reveal the true complexities of biology and disease. Already, our products have been adopted by researchers around the world, including 97 of the top 100 global research institutions and 19 of the top 20 global pharmaceutical companies, and have been cited in over 1,200 research papers on discoveries across the life sciences.
