Thermo Fisher Scientific Inc is the world leader in serving science, with annual revenue exceeding 30 billion dollar. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Post : Regulatory Affairs Specialist
Job Description :
• 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.
Candidate Profile :
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.
Additional Information
Experience : 4-8 years
Qualification : B.Pharm, B.Sc
Location : Bangalore
Industry Type : Pharma
End Date : 30th June, 2022
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