Description

You will lead hardware and reagent compliance initiatives, interpreting and implementing regulatory requirements (UL, CE, FCC, RoHS, REACH, etc.) and managing product certifications. Collaborating with cross-functional teams, you'll ensure products meet compliance standards throughout their lifecycle to enable successful launches and market access globally.

Requirements

• Bachelor’s degree in Electrical Engineering or related engineering field.
• 10+ years of experience in regulatory compliance for hardware products, reagents, or both—preferably in life sciences, diagnostics, or medical device industries.
• Experience with chemical and reagent compliance, including SDS authoring, GHS/CLP labeling, and familiarity with REACH, TSCA, and international chemical inventory regulations strongly preferred.
• Familiarity with environmental regulations (RoHS, REACH, WEEE, TSCA, etc.) and their application to product design and global distribution.
• Strong project management skills with ability to manage multiple regulatory timelines.
• Excellent technical writing and documentation skills.
• Ability to interpret regulatory language and apply practically.
• Experience with software coding is an added advantage.

Responsibilities

• Collaborating with cross-functional teams 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.
• Acting as liaison between 10x Genomics and regulatory agencies.
• Understanding RoHS, REACH, TSCA, WEEE and ensuring new/existing products comply.
• Determining and interpreting relevant regulatory standards such as IEC 61010-1, IEC 61010-2-010, IEC 61010-2-081, IEC 60601.
• Ensuring compliance with global EMC and EMI regulatory requirements.
• Staying up to date with changes to global agency approvals and testing procedures.
• Reviewing marketing, legal and technical documentation for compliance.
• Preparing manufacturing sites for regulatory body audits.
• Establishing routine manufacturing test equipment program for Hipot Ground Bond testing and managing bi-annual audits.