Work Flexibility : Hybrid

Knowledge of applicable international regulations and standards & Testing (21CFR, MDD & EU MDR, GSPR checklist, QSR, ISO 13485, IEC 60601 (including collateral and particular standards), IEC 60601-1-2 (EMI / EMC), PFAS, REACH, RoHS, WEEE, BWWR, Packaging & Packaging Waste Regulation, Biocompatibility, Battery Checklist etc.)

• Experienced with Test Report Forms of IEC standards, creation of regulatory and product compliance plans.
• Performs the coordination and preparation of document packages for compliance engineering evidence 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.
• Compiles all materials required in environmental compliance testing.
• Identifies / recommends 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 compliance testing to get market access for new and existing products. Advanced PC skills with proficiency in Microsoft Office Suite, including Excel. Works closely with cross functional team.

Qualifications

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 Compliance Testing or equivalent experience within medical device company, or similar organization.

Travel Percentage : 10%