Manager, Regulatory Affairs Aesthetic Medical Device; Bothell, WA

Role Summary

Manager, Regulatory Affairs Aesthetic Medical Device (Bothell, WA). This role focuses on ensuring medical device products comply with environmental, health, and safety regulations at the product level, with emphasis on environmental and chemical compliance. The position supports global market access by integrating environmental compliance requirements into product design, documentation, and lifecycle management.

• Product Environmental & Chemical Compliance
  • 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.
• Integration with Medical Device Regulatory & QMS
  • 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.
• Product Lifecycle & Change Management
  • 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.
• Supplier & Compliance Data Management
  • 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.
• Regulatory Intelligence & Advisory
  • 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.
• Other Regulatory Activities
  • Other tasks may be assigned on Regulatory Affairs, or per personal development goals.

• Bachelors degree in Environmental Science, Chemistry, Engineering, Materials Science, or related discipline.
• 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 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.
• This position will require west coast/PST working hours.