Boston Scientific Lead Regulatory Affairs 

India, Haryana, Gurugram 

247408354

India-Haryana, Gurgaon

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 : 7-8 years