Serve as the divisional Subject Matter Expert for Product Environmental Compliance (PEC), including internal/external audits, regulatory interpretation, evidence review, and authoring compliance reports.
Act as the Joint Replacement Division’s Process Owner (DPO) for PEC, influencing corporate and advocacy partners in relation to regulatory impacts and proposed changes.
Monitor emerging PEC directives and regulatory updates; assess business impact, recommend risk mitigation, and lead cross‑functional implementation projects for new and revised requirements.
Knowledge of applicable medical device and environmental regulations & standards (21CFR, MDD & EU MDR, GSPR checklist, QSR, ISO 13485, ISO 14971, PFAS, California Prop 65, REACH, EU POPs, RoHS, WEEE, BWWR, Packaging & Packaging Waste Regulation, Battery Checklist, Industry Specific Substances Restrictions and Declarations etc.)
Lead and collaborate with cross functional teams across the division, including engineering, regulatory, quality, sourcing, operations, and suppliers to set direction for PEC processes across the product lifecycle—from new product development through end‑of‑life.
Ensure the integration of PEC requirements into New Product Development (NPD) processes and post‑launch design change processes to ensure continued compliance and proper documentation.
Manage third‑party PEC evidence partners, oversee data integrity and trending, and create metrics, reporting and/or automation tools to enhance compliance visibility for leadership.
Serve as the primary point of contact for internal and external PEC inquiries, own PEC-related nonconformances, and ensure timely closure and accurate documentation.
Identify and implement process improvements for corporate and regulatory reporting, driving consistent, efficient, and high-quality compliance practices.
What You Will Need
Required Skills-
Bachelor’s degree in environmental science, Material Science/Engineering, Pharmaceutical Sciences, or related scientific/technical field.
Requires a minimum of 10 years Regulatory or Product Environmental Compliance or equivalent experience within medical device company, or similar organization.
Strong organizational, analytical, and problem‑solving skills with the ability to manage multiple projects and shifting priorities
Preferred Skills-
MS in environmental science, material science, engineering, pharmaceutical sciences, or related scientific/technical field
Experience in the medical device industry or other highly regulated fields (automotive, pharmaceutical, aerospace); in product environmental compliance (PFAS, California Prop 65, REACH, EU POPs, RoHS, WEEE, BWWR, Packaging & Packaging Waste Regulation, Battery Checklist, Industry Specific Substances Restrictions and Declarations etc.) and is also competent in EU MDR, US FDA & other regulations.
Knowledge of environmental regulations (RoHS, REACH, TSCA, EU MDR Restricted Substances, EU Packaging, Stockholm Convention, etc.)
Certifications such as NREP, CECM, or CEP
Demonstrated ability to influence cross‑functional teams and lead training initiatives to improve PEC awareness
Experience analyzing non‑routine regulatory issues and resolving complex compliance challenges
Travel Percentage: 10%
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