Manager of Product Compliance & Regulatory Affairs
A leading medical device innovator is seeking an experienced Product Compliance/Regulatory Manager to oversee global product‑level environmental and chemical compliance. This role is fully focused on product compliance, not site or occupational EHS, and plays a critical part in enabling global market access by ensuring devices and medicinal products meet evolving environmental, chemical, and safety regulations. The position operates on West Coast (PST) hours and reports into the Senior Director of Regulatory Affairs. This is an opportunity to shape compliance strategy across the product lifecycle, partner closely with Regulatory and Quality teams, and support cutting‑edge technologies entering global markets.
The Manager will be responsible for…
- Ensuring product compliance with global environmental and chemical regulations (RoHS, REACH/SVHC, P‑gas, WEEE, TSCA, Prop 65, etc.)
- Assessing materials, components, and substances for regulatory risk and compliance status
- Reviewing and approving product‑level documentation such as material declarations, supplier disclosures, SDS, and environmental certificates
- Supporting EU MDR technical documentation and contributing environmental compliance evidence for submissions
- Collaborating with Regulatory Affairs and Quality to align with ISO 13485, design controls, and change management
- Participating in risk management activities (ISO 14971) related to environmental and chemical risks
- Evaluating regulatory impact of design changes, supplier changes, and material substitutions
- Managing supplier environmental compliance programs and maintaining accurate compliance databases
- Supporting customer, notified body, and regulatory authority inquiries
- Monitoring global regulatory changes and advising internal teams on impact
The ideal candidate will have the following qualifications:
- Bachelor's degree in Environmental Science, Chemistry, Engineering, Materials Science, or related field
- 7+ years of experience in product environmental or chemical compliance, ideally within medical devices
- Strong understanding of RoHS, REACH, SVHC, P‑gas, and other global product chemical regulations
- Experience with EU MDR technical documentation and compliance annexes
- Experience supporting notified body audits or regulatory inspections
- Proficiency with PLM and EH&S compliance data management systems
- Strong documentation, regulatory interpretation, and cross‑functional collaboration skills
- Experience working within a regulated quality system (ISO 13485 preferred)