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

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


Job Location: Bothell, Washington, USA


Job Requisition ID: 14693


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.

Principle Responsibilities and Duties:

Note: The following are meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.

The EH&S Product Compliance Manager is responsible for ensuring that medical device and medicinal products comply with applicable environmental, health, and safetyregulations at the product level. This role focuses on product environmental and chemical compliance and does not include manufacturing site or occupational EHS responsibilities. The position supports global market access by integrating environmental compliance requirements into product design, documentation, and lifecycle management.

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.

Responsibilities

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.

Advisory and support to Regulatory Affairs strategy in matters of ERA (Environmental Risk Assessment) for medicinal products (20%)

• Ensure accurate evaluation of the product, proper interpretation of available data, and informed selection of any necessary experimental studies.
• Identify circumstances under which the absence of ERA studies may be justified.
• Organizing and coordination of the necessary experimental studies, when applicable.

Other Regulatory Activities

• Other tasks may be assigned on Regulatory Affairs, or per personal development goals

Safety

Solta Medical is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.

The range of starting base pay for this role is $115K-$158K. Actual starting pay will be based on a wide range of factors including, but not limited to, relevant skills, experience, qualifications, education and location. In addition to base pay, this position is eligible for participation in either (i) our annual bonus program or (ii) a sales incentive plan.

We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.