Regulatory Affairs-EH&S Product Reg. Comp. Manager Aesthetic Medical Device (WA)
Bausch Health Companies Inc.
13 hours ago
Remote friendly (Bothell, WA)
United States
$115,000 - $158,000 USD yearly
Corporate Functions
Qualifications
- Bachelor’s degree in Environmental Science, Chemistry, Engineering, Materials Science, or related discipline.
- 7+ years of experience in product environmental compliance and chemical compliance (preferably 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 EHS compliance data management systems.
- Experience in a regulated quality system environment (ISO 13485 preferred).
- Strong documentation, regulatory interpretation, and cross-functional collaboration skills.
- Background in toxicology and/or ecotoxicology (preferred/ideal).
Responsibilities
- Ensure product compliance with global environmental and chemical regulations (e.g., EU RoHS, REACH/SVHC, P-gas Regulation, WEEE, TSCA, Proposition 65).
- Assess materials, components, and substances for compliance and regulatory risk.
- Review/approve product-level compliance documentation (material declarations, supplier disclosures, SDS, environmental certificates).
- Collaborate with Regulatory Affairs and Quality for alignment with ISO 13485, design controls, and change management.
- Provide product environmental compliance evidence for regulatory submissions/technical documentation.
- Contribute to risk management (e.g., ISO 14971) for environmental/chemical-related risks.
- Embed environmental compliance requirements into product design and material selection; evaluate regulatory impact of changes/substitutions.
- Manage supplier environmental compliance programs and maintain compliance records/databases for audits and market access.
- Monitor regulatory changes and provide compliance guidance to stakeholders.
- Advisory/support to Regulatory Affairs for ERA for medicinal products (20%) including evaluating data, selecting studies, justifying absence of studies, and coordinating experiments when applicable.
Compensation/Benefits
- Starting base pay range: $115K–$158K; eligible for annual bonus or sales incentive plan.
- Bachelor’s degree in Environmental Science, Chemistry, Engineering, Materials Science, or related discipline.
- 7+ years of experience in product environmental compliance and chemical compliance (preferably 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 EHS compliance data management systems.
- Experience in a regulated quality system environment (ISO 13485 preferred).
- Strong documentation, regulatory interpretation, and cross-functional collaboration skills.
- Background in toxicology and/or ecotoxicology (preferred/ideal).
Responsibilities
- Ensure product compliance with global environmental and chemical regulations (e.g., EU RoHS, REACH/SVHC, P-gas Regulation, WEEE, TSCA, Proposition 65).
- Assess materials, components, and substances for compliance and regulatory risk.
- Review/approve product-level compliance documentation (material declarations, supplier disclosures, SDS, environmental certificates).
- Collaborate with Regulatory Affairs and Quality for alignment with ISO 13485, design controls, and change management.
- Provide product environmental compliance evidence for regulatory submissions/technical documentation.
- Contribute to risk management (e.g., ISO 14971) for environmental/chemical-related risks.
- Embed environmental compliance requirements into product design and material selection; evaluate regulatory impact of changes/substitutions.
- Manage supplier environmental compliance programs and maintain compliance records/databases for audits and market access.
- Monitor regulatory changes and provide compliance guidance to stakeholders.
- Advisory/support to Regulatory Affairs for ERA for medicinal products (20%) including evaluating data, selecting studies, justifying absence of studies, and coordinating experiments when applicable.
Compensation/Benefits
- Starting base pay range: $115K–$158K; eligible for annual bonus or sales incentive plan.