Reg Affairs EH&S Product Compliance Manager (Aesthetics Med Device) (Bothell WA)

Responsibilities

• Ensure product compliance with applicable global environmental and chemical regulations, including but not limited to: EU RoHS, REACH (including SVHC), P-gas Regulation, WEEE, TSCA, Proposition 65, and other relevant product environmental requirements.
• Assess materials, components, and substances used in medical devices for compliance and regulatory risk.
• Review and approve product-level compliance documentation, including material declarations, supplier disclosures, SDS, and environmental certificates.
• Collaborate with Regulatory Affairs and Quality to ensure alignment with ISO 13485, design controls, and change management processes.
• Support regulatory submissions and technical documentation by providing product environmental compliance evidence.
• Contribute to risk management activities (e.g., ISO 14971) by assessing environmental and chemical-related risks.
• Support product development teams in embedding environmental compliance requirements into product design and material selection.
• Evaluate regulatory impact of design changes, supplier changes, and material substitutions.
• Maintain product environmental compliance status throughout the product lifecycle.
• Manage supplier environmental compliance programs, including collection and review of RoHS/REACH declarations.
• Maintain accurate product compliance records and databases to support audits and market access.
• Support customer, notified body, and regulatory authority inquiries related to product environmental compliance.
• Monitor changes in global environmental and chemical regulations and assess impact on medical device products.
• Provide clear regulatory interpretation and compliance guidance to internal stakeholders.
• Advisory and support to Regulatory Affairs strategy in matters of ERA (Environmental Risk Assessment) for medicinal products (20%).
• Accurately evaluate the product, properly interpret available data, and informally select any necessary experimental studies.
• Identify circumstances under which the absence of ERA studies may be justified.
• Organize and coordinate the necessary experimental studies, when applicable.

Qualifications

• Bachelor’s degree in Environmental Science, Chemistry, Engineering, Materials Science, or related discipline.
• Seven years of experience in product environmental compliance, chemical compliance, preferably within the medical device industry.
• Solid understanding of RoHS, REACH, SVHC, and product chemical regulations applicable to medical devices.
• Experience with EU MDR technical documentation and product compliance annexes.
• Familiarity with P-gas Regulation and fluorinated substances used in medical devices or accessories.
• Experience supporting notified body audits or regulatory inspections.
• Experience with PLM and EH&S compliance data management systems.
• Experience working within a regulated quality system environment (ISO 13485 preferred).
• Strong documentation, regulatory interpretation, and cross-functional collaboration skills.
• Experienced professional, ideally with a strong background in toxicology and/or ecotoxicology.