Manager, Regulatory Affairs (Aesthetic Medical Device) (Bothell, WA)

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

Manager, Regulatory Affairs (Aesthetic Medical Device) - Bothell, WA - Job Location: Bothell, USA - Job Requisition ID: 15763

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.

The EH&S Product Regulatory Compliance Manager ensures that the company's medical device and medicinal products comply with applicable global product-level environmental, health, safety, and chemical regulations, supporting global market access by integrating these requirements into product design, technical documentation, and lifecycle management. The role also advises Regulatory Affairs on Environmental Risk Assessment (ERA) for medicinal products and does not cover manufacturing site or occupational EHS.

• Ensure products comply with applicable global environmental and chemical regulations, including EU RoHS, REACH (including SVHC), the F-gas Regulation, WEEE, TSCA, and California Proposition 65

• Assess materials, components, and substances used in medical devices for compliance and regulatory risk, and contribute environmental and chemical risk inputs to ISO 14971 risk management

• Review and approve product-level compliance documentation, including material declarations, supplier disclosures, Safety Data Sheets (SDS), and environmental certificates

• Provide product environmental compliance evidence for regulatory submissions and EU MDR technical documentation, in alignment with ISO 13485 design controls and change management processes

• Partner with product development teams to embed environmental compliance requirements into product design and material selection

• Evaluate the regulatory impact of design changes, supplier changes, and material substitutions, and maintain product environmental compliance status throughout the product lifecycle

• Manage the supplier environmental compliance program, including collection and review of RoHS/REACH declarations, and maintain accurate product compliance records and databases

• Respond to customer, notified body, and regulatory authority inquiries on product environmental compliance, and support related audits and inspections

• Monitor changes in global environmental and chemical regulations, assess their impact on products, and provide clear regulatory interpretation and guidance to internal stakeholders

• Advise Regulatory Affairs on Environmental Risk Assessment (ERA) for medicinal products (approx. 20% of role): evaluate product data, determine whether experimental studies are needed or their absence can be justified, and coordinate required studies

Qualifications

Bachelor Required,m inimum 6years of experience

Relevant field of study, if applicable: Environmental Science, Chemistry, Toxicology, Engineering, Materials Science, or related discipline

Functional / Technical Knowledge: Product environmental and chemical compliance, preferably in the medical device industry; RoHS, REACH, SVHC, and product chemical regulations applicable to medical devices; F-gas Regulation and fluorinated substances used in medical devices or accessories; EU MDR technical documentation and product compliance annexes; supporting notified body audits or regulatory inspections; PLM and EH&S compliance data management systems; regulated quality system environments (ISO 13485 preferred); regulatory interpretation, technical documentation, and cross-functional collaboration. A background in toxicology and/or ecotoxicology is an advantage

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.

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.