Executive - Regulatory Affairs
- Bangalore, Karnataka
- Permanent
- Full-time
- Have regular meetings with international Regulatory Teams of Halma Companies to understand their evolving business needs wrt Indian market.
- Assist them in understanding the India MDR with clarity.
- Serve as a consultant, advisor and guide to the International Regulatory team with a solution orientation.
- Reach out to CDSCO or travel to Delhi for mtg with regulatory officers to seek clarification.
- Tap into External India MDR Consultant as and when required.
- Evaluate, Recommend, Implement and Use technology and platforms to manage licences and process flows for multiple Operating Companies within the Group.
- Minimise risk to business disruption from regulation.
- Agile and responsive to changing regulatory environment and evolving business needs.
- Use MTAI membership effectively for advocacy as well as position Halma’s point of view whenever required.
- In addition, there are regulatory license applications for PESO to be also managed with a list of documents.
- GEM portal registration for Halma companies based abroad including providing checklist, outlining process, following up for documents, submission of the same, and facilitating online video audits of the factories.
- Executional Rigor, Due diligence wrt to Documentation, and Process Oriented for day-to-day MDR Licensing requirement.
- Understands varying needs across diverse stakeholders – especially different types of medical devices.
- Transparent and effective communicator with all stakeholders, and commercially savvy when recommending solutions.
- Deep and Clear understanding of evolving India MDR.
- Degree in Regulatory Management.
- Minimum 1 to 3 years of relevant experience.
- Core end-to-end experience in India MDR.
- Experience in Regulatory License platforms.
- Exposure to Legal Metrology & Labelling, UDI, MRP/Pricing/Trade Margins, Customs and other related operational issues.
- Exposure to European MDR and FDA would be advantageous.