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Lead, Regulatory Affairs at Boston Scientific Corporation Malaysia

Gurugram, haryana, India -

Full Time

Start Date

Immediate

Expiry Date

06 Jan, 26

Salary

0.0

Posted On

08 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Medical Device Dossier, Clinical Trials, License Transfers, Import License, New Product Approvals, Change Management, Technical Literature, Stakeholder Management, Regulatory Compliance, Technical Queries, Labeling Information, Warehouse License, Business Acumen, Project Planning, Executive Summaries

Industry

Medical Equipment Manufacturing

Description

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 Graduate/Postgraduate in any life sciences/Engineering 8+ years of relevant experience

Responsibilities

The role involves compiling medical device dossiers according to Indian regulatory requirements and managing regulatory compliance. It includes regular follow-ups with regulatory authorities and addressing technical queries from both regulators and internal stakeholders.