Senior Specialist Regulatory Affairs

MNC Company in Life science - Safety/Protective Equipments

1. Responsible for all medical device registration submission under in India and Indian subcontinent countries as required. Ensure medical devices in the designated geographies obtained approval status before commercialization.
2. Maintain the device registration status and ensure timely re-registration.
3. Provide support the local distributors in India subcontinent countries to register devices when required.
4. Provide guidance and advice in Legal and Regulatory requirements including mandatory label marking requirements.
5. Responsible to review and approve the relevant artwork, package label and marketing materials from regulatory and customs aspects covering inhouse and outsourced product portfolio.
6. Ensures labels for India meet Package Commonality Rules and Customs requirements.
7. Evaluates, reviews and approves product claims on labels and marketing collaterals in accordance to legal and regulatory requirements.
8. Maintains label marking and guidance templates for MED and PPE/ SU products.
9. Provides professional advice, propose feasible solutions and supports local cross- functional teams in business decision making process.
10. Identify strategy for change management to product and business. Establish plan to ensure effective implementation. Consults the respective governmental agencies on regulatory requirements for new products and major changes in existing products.
11. Supports re-registration / change notifications activities as relevant for changes made to registered devices / products in India and Indian sub-continent countries
12. Monitors the regulation changes and communicate the information in a timely manner to ensure compliance to the requirements.
13. Communicates with the relevant medical device agencies and other related government agencies to address any regulatory matters raised by the agency including product registration, pre market evaluation and post market surveillance matters.
14. Reviews, comments and provides feedback to related governmental agencies with regards to draft regulations issued by the agency.
15. Liaise with Regulatory agencies, Legal counsel and external counsel as relevant to understand and apply the requirements to products and processes.
16. Communicate changes in regulatory directions, regulatory intelligence and competitive activities. Notify internally via RA Notification as necessary within all relevant regulatory matters.
17. Support and provide training to cross functional teams in understanding the regulatory requirements to ensure compliance.
18. Work with Global Business Units (GBUs), Research & Development, Technical Services, Legal and Regulatory Affairs management teams to deliver appropriate regulatory strategies and technical support throughout the product lifecycle.
19. Supports post market surveillance and vigilance activity when it is required.
20. Attends / participates in various agencies / standard bodies meetings internally or externally with regulatory authorities or professional organization.
21. Maintain and upkeep of all regulatory information, technical file, licenses, and certificates

Senior Regulatory Affairs