Environmental Regulatory Affairs Manager (Medical Devices)

Bausch Health; Bothell (WA); On-site; USD 115,000 - 158,000; Full time

Job summary

Solta Medical in Bothell, WA seeks a Manager of Regulatory Affairs for Aesthetic Medical Devices to lead environmental compliance efforts across global markets. The role focuses on integrating environmental, chemical and regulatory requirements into product design, documentation, and lifecycle management.

The position covers ERA for medicinal products and ensures EU MDR technical documentation alignment, with collaboration across development teams and support for audits and regulatory inquiries.

Qualifications

• Bachelor's degree in a relevant environmental/technical field and at least 6 years of experience.
• Experience in product environmental and chemical compliance for medical devices.
• Knowledge of RoHS, REACH, SVHC, F-gas Regulation, EU MDR.
• Experience supporting regulatory audits and inspections.
• Familiarity with ISO 13485 and regulatory documentation.

Responsibilities

• Ensure products comply with environmental and chemical regulations globally.
• Assess materials and substances for regulatory risk.
• Review and approve product environmental compliance documentation.
• Provide evidence for regulatory submissions and EU MDR docs.
• Partner with product development to embed compliance in design.
• Evaluate regulatory impact of design/supplier changes.
• Manage supplier environmental compliance program.
• Respond to inquiries and audits.

Skills

Regulatory compliance

Environmental risk

Documentation management

Cross-functional collaboration

Education

Bachelor's degree in Environmental Science or related

Field: Engineering, Chemistry, Toxicology

Tools

PLM software

EH&S data systems

Job description

Solta Medical in Bothell, WA seeks a Manager of Regulatory Affairs for Aesthetic Medical Devices to lead environmental compliance efforts across global markets. The role focuses on integrating environmental, chemical and regulatory requirements into product design, documentation, and lifecycle management.

The position covers ERA for medicinal products and ensures EU MDR technical documentation alignment, with collaboration across development teams and support for audits and regulatory inquiries.