Lead, Regulatory Affairs

2 days ago

Gurgaon, Haryana, India Boston Scientific Full time

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 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

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

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