Lead, Regulatory Affairs (Gurugram)

Lead, Regulatory Affairs (Gurugram)

04 Aug
|
BOSTON SCIENTIFIC
|
Gurugram

04 Aug

BOSTON SCIENTIFIC

Gurugram

Additional Locations N A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific we ll give you the opportunity to harness all that s within you by working in teams of diverse and high-performing employees tackling some of the most important health industry challenges With access to the latest tools information and training we ll help you in advancing your skills and career Here you ll be supported in progressing - whatever your ambitions Location Gurugram India Key Responsibilities Compilation of Medical Device Dossier w r t Indian regulatory requirements for Registration Clinical Trial Permissions License Transfers Import License New Product Approvals Renewals Regular follow-ups with CDSCO Work with other regulatory authorities like Atomic Energy Review Board AERB Department of Telecommunication DoT Legal Metrology etc Framework Medical Write-ups and Executive summaries Addressing Technical Queries both from regulators and internal stakeholders Change Management including tracking and submission of product site changes Acquisition related submissions project planners and follow-ups Preparation of Technical literature presentation s w r t Subject Expert Committee meetings Communicate current local requirement new product registration update in labelling information update in MRP to labelling team and ensure correctness in label release Application for new warehouse license or amendment in the existing warehouse license Applies understanding of business acumen and stakeholder management to accomplish the project Demonstrates knowledge of the company processes and customers Uses prescribed guidelines or policies in analyzing situations and resolving problems to deliver continuous business results Provide informal guidance to team members Regulatory Compliance Management Mapping imports with existing approvals Mapping current practices with existing regulations Requirements Graduate Postgraduate in any life sciences Engineering 8 years of relevant experience Requisition ID 614765 As a leader in medical science for more than 40 years we are committed to solving the challenges that matter most - united by a deep caring for human life Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives create value for our customers and support our employees and the communities in which we operate Now more than ever we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen So choosing a career with Boston Scientific NYSE BSX isn t just business it s personal And if you re a natural problem-solver with the imagination determination and spirit to make a meaningful difference to people worldwide we encourage you to apply and look forward to connecting with you

📌 Lead, Regulatory Affairs (Gurugram)
🏢 BOSTON SCIENTIFIC
📍 Gurugram

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