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