Boston Scientific Senior Lead Regulatory Affairs 

India, Haryana, Gurugram District 

953841452

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 new 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

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.