Thermo Fisher Hiring Bachelor’s degree for Regulatory Affairs Specialist-Apply Now

Responsibilities

• This position supports the regulatory lead of LSLPG, GSG and BPG India business.
• Compilation and review of registration application, online (Sugam portal)/hard copy submissions to MD/IVD sections of CDSCO (Central Drug Standard Control Organization), New Delhi.
• Prepare and submit regulatory submissions to the Authorities in South Asia and lead type test/clinical studies where needed in support of the product filings.
• Getting the product change notifications implemented for LSLPG, GSG and BPG products.
• Preparation, verification & maintenance of various documents like device master file, site master file, technical file as per requirements of various countries regulatory body like CDSCO, CE-MDR, USFDA etc.
• Following up with CS team to get the field safety corrective actions implemented for LSLPG, GSG and BPG products.
• Support Post Market Surveillance of regulated products in India. Work with cross functional teams, operations, and customers to resolve and implement corrective and preventive actions resulting from technical complaints.
• Applying Duel Use NOC for India customs clearance.
• Liaison with Authorities /officials to ensure timely approvals & availability of valid licenses.
• Regulatory liasioning and follow up with CDSCO office for status of applications and for any new update regarding our registered products.
• Teleconferences with global affiliates to process and clarifications on documents for ease of applications to be submitted as CDSCO.
• Support LSG Indian Plant QMS/GMP and implement regulatory affairs activities.
• Participate in company regulatory/quality audits and assist, as needed.
• Other tasks assigned by line manager.

Requirement

• Bachelor’s degree or higher degree in Engineering, Pharmacy, Sciences or Medicine.
• Over 4-8 years relevant experience of premarket & post market work on compliance to Medical Device Rules (MDR) 2017 governed by Central Drug Standard Control Organization (CDSCO) for IVD & other medical devices.