Global Environmental Regulatory Lead — Medical Devices

Bausch Health Companies Inc.; Bothell (WA); Sur place; USD 115 000 - 158 000; Plein temps

Résumé du poste

Bausch Health Companies Inc. in Bothell, WA is seeking an EH&S Product Regulatory Compliance Manager to ensure medical devices and medicinal products meet global environmental, health and chemical regulations across product design and lifecycle.

You will integrate requirements into technical documentation, advise on ERA for medicinal products, and partner with development teams to embed environmental compliance into design, while supporting regulatory submissions and audits.

Qualifications

• Bachelor degree in Environmental Science, Chemistry, Toxicology, Engineering, or related discipline.
• Minimum 6 years of experience in regulatory compliance for medical devices or related field.
• Strong knowledge of RoHS, REACH, SVHC, F-gas regulations, EU MDR documentation and audits.

Responsabilités

• Ensure products meet global environmental and chemical regulations.
• Assess materials and substances for regulatory risk.
• Review and approve environmental documentation and SDS.
• Provide regulatory evidence for EU MDR documentation.
• Partner with development teams to embed compliance into design.
• Manage supplier environmental compliance program.
• Respond to inquiries and support audits.
• Monitor regulatory changes and provide guidance.
• Advise on ERA for medicinal products (approx. 20%).

Connaissances

Regulatory compliance

Environmental compliance

RoHS/REACH

ISO 13485

Regulatory submissions

Formation

Bachelor's degree

Description du poste

Bausch Health Companies Inc. in Bothell, WA is seeking an EH&S Product Regulatory Compliance Manager to ensure medical devices and medicinal products meet global environmental, health and chemical regulations across product design and lifecycle.

You will integrate requirements into technical documentation, advise on ERA for medicinal products, and partner with development teams to embed environmental compliance into design, while supporting regulatory submissions and audits.