Lead, Regulatory Affairs

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.

Job Responsibilities:

• Mapping of regulatory requirements for functioning of R&D premise.
• Conduct regular gap assessments to identify new regulatory requirements (if any) with regards to functioning of the R&D premises and monitor compliance.
• Ensure compliances to applicable acts and rules viz. Drugs & Cosmetics Act, 1940 and Rules 1945, Medical Device Rules, 2017 and others.
• Identify and support the warehouse licensing requirements (including registration certificate for warehouse)
• Work with R&D teams to identify the requirements for test licenses for importing products for test, evaluation, demonstration or training.
• Strategize, plan and compile test license application and follow up with CDSCO for approval.
• Collaborate with R&D teams to provide regulatory guidance throughout the product development.
• Continuous scanning of the regulatory environment and communication to the R&D team on any new/changing regulations along with impact assessment and mitigation.
• Support R&D team for recognition of in-house R&D units (RDI) from Department of Scientific and Industrial Research (DSIR).
• Collaborate with R&D QA team to establish and streamline internal processes.
• Support internal audits and inspections by external agencies (CDSCO/State FDAs/etc.).
• Coordinate with sourcing and warehouse team for importation of goods for R&D purpose and regulatory clarification to ADC/customs, wherever required.
• Compilation of Medical Device Dossier w.r.t Indian regulatory requirements for Registration, 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.
• Addressing Technical Queries both from regulators and internal stakeholders
• Change Management including tracking and submission of product/ site changes
• Applies understanding of business acumen and stakeholder management to accomplish the project
• Uses prescribed guidelines or policies in analyzing situations and resolving problems to deliver continuous business results
• Skills required:
  • Good English Communication Skills Verbal and Written
  • Problem solving
  • Stakeholder management
  • Software Skills: MS Office

• Qualification Graduate/Postgraduate in any life sciences/Engineering
• Experience 7+ Years

Requisition ID: 612914

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!