Gautham A Email & Phone Number

Gurugram, Hr, In

India

Regulatory Affairs lead for Synthes (Trauma, Cranio - Maxillo Facial, Powertools), Depuy Joints (Hip, Knee & Shoulder), DePuy Spine, Codman CNS (Divested) and Velys Portfolio (Robotics) businesses of Johnson & Johnson Pvt Ltd.• Responsible for Ethicon (Wound closure and Biosurgery) and Biosense Webster since 2023. Prior responsibilities included DePuy Joints, Synthes (Trauma, CMF, Spine and Power tools) and Digital Portfolio• Responsible for evaluation of Business Unit (BU)… Show more Regulatory Affairs lead for Synthes (Trauma, Cranio - Maxillo Facial, Powertools), Depuy Joints (Hip, Knee & Shoulder), DePuy Spine, Codman CNS (Divested) and Velys Portfolio (Robotics) businesses of Johnson & Johnson Pvt Ltd.• Responsible for Ethicon (Wound closure and Biosurgery) and Biosense Webster since 2023. Prior responsibilities included DePuy Joints, Synthes (Trauma, CMF, Spine and Power tools) and Digital Portfolio• Responsible for evaluation of Business Unit (BU) regulatory strategy and compliance programs and translate to functional and individual goals for execution• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop implementable solutions with other members of regulatory and cross-functional teams• Monitor regulatory changes, gap analysis, and plan required changes to ensure compliance to current regulatory guidelines• Help effectively manage any identified non-conformity• Assist in the development of new procedures, SOP's and WI’s and train key personnel on them• Define regulatory pathway for Medical device based on the intended use and risk classification of the product• Monitor the impact of changing regulations on proposed submissions and update internal stakeholders• Review and approve product labeling to ensure compliance with regulation• Identify and develop RA staff by making accurate assessments of an individual's capabilities and performance, and providing feedback, coaching, guidance, and mentoring Show less

Regulatory Affairs lead for Synthes (Trauma, Cranio - Maxillo Facial, Powertools), Depuy Joints (Hip, Knee & Shoulder) and Codman CNS businesses of Johnson & Johnson Pvt Ltd

Gurgaon, India

Master’S Degree, Biomedical/Medical Engineering

Bachelor Of Engineering (Beng), Biomedical/Medical Engineering

Education record