Regulatory Affairs-EH&S Product Reg. Comp. Manager Aesthetic Medical Device (WA)

Role Summary

The EH&S Product Compliance Manager, Regulatory Affairs - Aesthetic Medical Device, ensures that medical devices and medicinal products meet applicable environmental, health, and safety regulations at the product level. This role concentrates on product environmental and chemical compliance rather than manufacturing site or occupational EHS responsibilities. It supports global market access by integrating environmental compliance requirements into product design, documentation, and lifecycle management. Location options include Bridgewater, New Jersey, USA or Bothell, Washington, USA.

Responsibilities

• Ensure product compliance with global environmental and chemical regulations, including EU RoHS, REACH (including SVHC), P-gas Regulation, WEEE, TSCA, Proposition 65, and other relevant 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 align 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 regulatory interpretation and guidance to internal stakeholders.
• Advisory and support to Regulatory Affairs strategy in Environmental Risk Assessment (ERA) for medicinal products (20%): ensure accurate evaluation of the product, interpretation of data, and coordination of necessary studies; identify when ERA studies may be justified or unnecessary.
• Other regulatory activities as assigned.

Qualifications

• 7+ 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 EHS 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 with a strong background in toxicology and/or ecotoxicology.

Education

• Bachelor’s degree in Environmental Science, Chemistry, Engineering, Materials Science, or related discipline.