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Manager, EHS Product Regulatory Compliance
This role ensures medical device and pharmaceutical products meet global environmental and chemical compliance requirements. Focused at the product level (not site EHS), the Manager partners across Regulatory, Quality, and R&D to support market access by embedding compliance into product design and lifecycle management. What You’ll Do
- Ensure compliance with global environmental and chemical regulations (e.g., RoHS, REACH, SVHC, WEEE, TSCA, Prop 65)
- Assess materials and components for regulatory risk and compliance
- Review and maintain product documentation, including material declarations, SDS, and supplier disclosures
- Partner with Regulatory Affairs and Quality to support submissions and align with ISO 13485 and design control processes
- Contribute to risk management activities (e.g., ISO 14971) with a focus on environmental and chemical risks
- Support product development by integrating compliance requirements into design and material selection
- Evaluate the impact of design, supplier, or material changes on regulatory compliance
- Manage supplier compliance data and maintain accurate records for audits and inspections
- Respond to inquiries from customers, notified bodies, and regulators
- Track evolving global regulations and provide clear guidance to internal teams
- Support Environmental Risk Assessments (ERA) for medicinal products, including data evaluation and study coordination when needed What You Bring
- Bachelor’s degree in Environmental Science, Chemistry, Engineering, Materials Science, or related field
- 7+ years of experience in product environmental or chemical compliance (medical device experience preferred)
- Fluency in Mandarin
- Strong knowledge of global regulations such as RoHS, REACH, SVHC, and related frameworks
- Familiarity with EU MDR technical documentation and compliance requirements
- Experience working in regulated environments (ISO 13485 preferred)
- Exposure to supplier compliance programs and regulatory audits
- Experience with PLM or EH&S data systems
- Background in toxicology or ecotoxicology is a plus Apply To this Job Apply To This Job