Sr. Staff Engineer Product Environmental Compliance (PEC)

What You Will Do:

• 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 Divisions 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 crossfunctional 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 lifecyclefrom new product development through endoflife.
• Ensure the integration of PEC requirements into New Product Development (NPD) processes and postlaunch design change processes to ensure continued compliance and proper documentation.
• Manage thirdparty 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-

• Bachelors 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 problemsolving 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 crossfunctional teams and lead training initiatives to improve PEC awareness
• Experience analyzing nonroutine regulatory issues and resolving complex compliance challenges