Regulatory Affairs Specialist - Medical Devices

JOB SUMMARY:

Obtain timely regulatory approvals of all Medical Devices marketed in India and Sub-continent countries and liase with Product Divisions, manufacturers and government officials on regulatory requirements.

RESPONSIBILITIES:

- Engaging in core Regulatory activities including:

Liaise with manufacturers to obtain documents for device submissions in India and Sub-continent countries.

Submit applications for all regulated devices to Drug Controller General of India (DCGI) office.

Submit applications for all the products using Radio Frequency (RF) to Wireless Planning and Co-ordination (WPC) office.

Assemble technical documentation for inclusion in regulatory dossiers for submission to DCGI and WPC office.

Interface with DCGI and WPC officers to resolve Regulatory issues affecting the company.

Coordinate and respond to requests received from DCGI, WPC office and Sub-continent countries Regulatory agency.

Liaise with manufacturers regarding device modifications and timing of future device submissions.

Ensuring upload of regulatory submissions dossiers (New/ Endorsement/ Renewal/ change note/ Queries/ Query responses) on Asia Sharepoint and India Document Management System (DMS).

Ensuring registration certificates and Import licenses for approved devices are current and up to date on India sharepoint.

Achieve timely approval of Medical devices to enable the marketing of these products in India.

Support company sales targets through timely product approvals aligned with Marketing strategies.

Support Sales team to provide regulatory documents coordinated with US RA team for tender submissions.

- Maintain Approval tracking documentation for India and Sub-continent countries.

- Develop and maintain RA strategic plans for future key technology products.

- Build strong relationships with manufacturers to facilitate their understanding of South Asia's regulatory requirements.

- Co-ordinate with Supply Chain and US RA team to track approvals nearing expiration in the near future to plan inventory accordingly.

- Create Regulatory Affairs monthly report.

- Support Manager in preparing for Quarterly Business Review Meetings.

- Support Manager in preparing for AOP for Regulatory Affairs Function.

- Convene Regulatory meetings.

- Helping the supply chain in removal of GTS block on products as and when required

- Perform other related functions and responsibilities as directed by Manager.

QUALIFICATIONS:

Masters in Pharmacy/ Biotechnology/ MBA in Pharmaceutical administration with 3-4 years of Regulatory experience with CDSCO office. Regulatory Experience in Medical Devices preferred.