Senior Compliance Engineer

About the role

The is a critical role focused on the end-to-end management of hardware and reagent regulatory initiatives on a global scale. The successful candidate will own the strategic oversight of product certifications, ensuring alignment with international directives and standards. This position requires close collaboration with cross-functional teams to embed compliance into the product lifecycle from the earliest design stages through to market release. The role is responsible for interpreting complex regulatory requirements and translating them into actionable controls for engineering and manufacturing. You will safeguard the company by ensuring all products meet rigorous safety, health, and environmental standards globally. This position plays a key role in enabling 10x Genomics to operate with integrity and market leadership in highly regulated life sciences markets. Ultimately, the Senior Compliance Engineer acts as the central expert and gatekeeper for regulatory adherence across the organization.

Key facts

What you'll do

• Coordinate with engineering, quality, and regulatory teams to verify that all hardware products meet global safety standards including UL, CSA, FCC, CE, KCC, SRRC, PSE, and CB.
• Serve as the primary liaison with certification bodies, submitting official certification paperwork and managing the entire documentation trail to facilitate smooth and efficient audits.
• Analyze product designs and documentation to ensure strict adherence to chemical and environmental regulations such as RoHS, REACH, TSCA, and WEEE.
• Apply a detailed understanding of critical safety standards such as IEC 61010-1, IEC 61010-2-010, IEC 61010-2-081, and IEC 60601 to guide and validate product design decisions.
• Define, implement, and maintain specific design guidelines for shielding, grounding, and PCB layout to ensure products consistently meet EMC and EMI requirements.
• Conduct thorough reviews of technical documentation, user manuals, and declarations of conformity to ensure accuracy, completeness, and regulatory alignment before release.
• Prepare and manage manufacturing sites for regulatory surveillance audits, overseeing the implementation of robust testing programs and ensuring readiness for bi-annual product safety certification assessments.
• Develop and implement a routine manufacturing test program specifically for high-potential risks, focusing on Hipot and Ground Bond testing to ensure electrical integrity.
• Partner with supply chain and procurement to ensure all reagents and associated materials comply with chemical safety and regulatory standards.
• Drive continuous improvement in compliance processes by identifying gaps, implementing corrective actions, and updating procedures to reflect changes in global regulations.
• Act as the compliance expert during product development reviews, providing clear guidance to resolve potential regulatory conflicts proactively.
• Maintain a detailed understanding of the regulatory landscape for life sciences diagnostics and hardware, anticipating changes and ensuring timely adaptation.
• Support the commercialization of new products by providing clear compliance pathways and strategies to meet market-specific requirements.
• Generate comprehensive reports and summaries for executive leadership regarding the status of regulatory compliance and audit readiness.

Requirements

• Hold a Bachelor degree in Electrical Engineering or a related technical field as the foundational qualification for this role.
• Bring a minimum of 10+ years of cumulative experience in regulatory compliance, specifically focused on hardware or reagents within highly regulated sectors.
• Demonstrate deep expertise in electrical engineering processes, safety standards, and the technical procedures required for global product certification.
• Proven ability to manage complex, concurrent project timelines while balancing priorities across R&D, supply chain, manufacturing, and quality teams.
• Possess strong technical writing capabilities to produce precise regulatory submissions, audit reports, and compliance documentation.
• Show a talent for translating dense, complex regulatory language into practical, actionable design constraints and compliance strategies for engineering teams.
• Must be eligible to work in Singapore and legally authorized to accept employment in the country without requiring sponsorship, as the company will not provide work visa sponsorship for this role.
• Experience working within a life sciences, medical device, or diagnostics environment is essential due to the strict regulatory nature of the products.

Nice to have

• Hands-on experience with chemical and reagent compliance, including authoring Safety Data Sheets (SDS) and applying GHS/CLP labeling classifications.
• Working knowledge of REACH and TSCA regulations specific to chemical substances used in manufacturing or product components.
• Proficiency in software coding or scripting is advantageous for automating compliance tasks and data management.

Practical notes

This is an on-site position based in the Singapore office, requiring consistent presence during standard business hours. 10x Genomics does not accept unsolicited applications from recruitment agencies or third-party agencies. All official communication regarding this role will originate exclusively from email addresses ending in 10xgenomics.com. Applicants are advised to monitor their spam folders and ensure communications are not filtered improperly. The company is an equal opportunity employer and welcomes diverse candidates to apply.