Medical Devices & Regulations

Must-Have SkillsStrong expertise in V&V for medical devicesHands-on experience in:Protocol writing (IQ, OQ, PQ, CSV, system validation)Validation execution and reportingDeep understanding of:FDA regulations (21 CFR Part 820)ISO 13485 standardsRisk management (ISO 14971)Experience in regulated environments with minimal supervisionAbility to independently manage multiple protocols simultaneouslyKey Responsibilities:· Independently author, review, and execute V&V protocols (IQ/OQ/PQ, system validation, software validation, etc.)· Ensure all validation activities comply with regulatory standards (FDA, ISO 13485, 21 CFR Part 820)· Drive end-to-end protocol lifecycle, including:o Protocol authoringo Test executiono Documentation and reportingo Defect tracking and resolution· Collaborate with cross-functional teams (R&D, Quality, Manufacturing, Regulatory)· Provide SME-level inputs for validation strategy and risk-based validation approaches· Support audit readiness and documentation for regulatory inspections· Work in a high-paced environment with immediate delivery expectationsGeneric Managerial Skills, If any1. Leadership2. Communication Skills3. Stakeholder Management4. Decision Making5. Problem Solving6. Mentoring & Coaching7. Conflict Resolution8. Strategic Thinking9. Time & Priority Management10. Adaptability & FlexibilityDesirable Skills:Keyword:Skills: ISO 13485~EIS : Medical Device & RegulationsExperience Required: 10 & AboveEmail ID: Vipula.p@configusa.com