Sr. RA Specialist- Product Environmental Compliance

Work Flexibility: Hybrid

What you will do-

• Possesses and applies a broad knowledge and understanding of the product environmental compliance requirements, legislation, processes, and procedures.
• 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.)
• Experienced with BOMCheck gap assessment for supplier declarations and updating corresponding environmental summary reports.Performs the coordination and preparation of document packages for evidence related to product environmental regulations to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections.
• Coordinates, schedules, prepares, and compiles documents for review & submission to regulatory agencies.Identifies / supports procedural updates, changes in labeling, manufacturing processes, and participates in development and implementation of the same.Keeps abreast of regulatory/ State of the art changes.
• Possesses and applies a broad knowledge and understanding of regulations, processes, and procedures.Judgement in applying professional expertise and is expected to work independently with minimal supervision.Communicate and collaborate internally and externally during product development process.
• Requires attention to detail in making evaluative judgements based on the analysis of information.
• Conducts analytical research and provides expertise on product environmental compliance requirements to get market access for new and existing products.
• Advanced PC skills with proficiency in Microsoft Office Suite, including Excel, Power BI.
• Works closely with cross functional team.

What you will need-

This position requires professional mastery of a specialized field of engineering that requires a bachelor’s degree in mechanical engineering, Electrical Engineering, Science, environmental science or equivalent focus or equivalent certification.

Professional knowledge gained through substantial applicable work experience, to supplement formal knowledge, to apply principles and concepts of own subject/technical discipline in resolving issues as they arrive. 

Requires a minimum of 5 or more years’ Regulatory or Product Environmental Compliance or equivalent experience within medical device company, or similar organization.

Knowledge of applicable environmental regulations for US and OUS- PFAS, REACH, RoHS, WEEE, BWWR, Packaging & Packaging Waste Regulation, Biocompatibility, Battery Checklist etc.)