Manager, Regulatory Affairs (Aesthetic Medical Device) (Bothell, WA)
About The Position
Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it—where your skills and values drive our collective progress and impact. The EH&S Product Regulatory Compliance Manager ensures that the company’s medical device and medicinal products comply with applicable global product-level environmental, health, safety, and chemical regulations, supporting global market access by integrating these requirements into product design, technical documentation, and lifecycle management. The role also advises Regulatory Affairs on Environmental Risk Assessment (ERA) for medicinal products and does not cover manufacturing site or occupational EHS.
Requirements
- Bachelor Required, minimum 6 years of experience
- Relevant field of study, if applicable: Environmental Science, Chemistry, Toxicology, Engineering, Materials Science, or related discipline
- Functional / Technical Knowledge: Product environmental and chemical compliance, preferably in the medical device industry; RoHS, REACH, SVHC, and product chemical regulations applicable to medical devices; F-gas Regulation and fluorinated substances used in medical devices or accessories; EU MDR technical documentation and product compliance annexes; supporting notified body audits or regulatory inspections; PLM and EH&S compliance data management systems; regulated quality system environments (ISO 13485 preferred); regulatory interpretation, technical documentation, and cross-functional collaboration.
- A background in toxicology and/or ecotoxicology is an advantage
Responsibilities
- Ensure products comply with applicable global environmental and chemical regulations, including EU RoHS, REACH (including SVHC), the F-gas Regulation, WEEE, TSCA, and California Proposition 65
- Assess materials, components, and substances used in medical devices for compliance and regulatory risk, and contribute environmental and chemical risk inputs to ISO 14971 risk management
- Review and approve product-level compliance documentation, including material declarations, supplier disclosures, Safety Data Sheets (SDS), and environmental certificates
- Provide product environmental compliance evidence for regulatory submissions and EU MDR technical documentation, in alignment with ISO 13485 design controls and change management processes
- Partner with product development teams to embed environmental compliance requirements into product design and material selection
- Evaluate the regulatory impact of design changes, supplier changes, and material substitutions, and maintain product environmental compliance status throughout the product lifecycle
- Manage the supplier environmental compliance program, including collection and review of RoHS/REACH declarations, and maintain accurate product compliance records and databases
- Respond to customer, notified body, and regulatory authority inquiries on product environmental compliance, and support related audits and inspections
- Monitor changes in global environmental and chemical regulations, assess their impact on products, and provide clear regulatory interpretation and guidance to internal stakeholders
- Advise Regulatory Affairs on Environmental Risk Assessment (ERA) for medicinal products (approx. 20% of role): evaluate product data, determine whether experimental studies are needed or their absence can be justified, and coordinate required studies
Benefits
- annual bonus program
- sales incentive plan
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Manager
