Regulatory Affairs – CDSCO Vacancies in Noida Corpseed
Corpseed, a well-established player in regulatory compliance for medical devices, pharmaceuticals, and more, is offering exciting opportunities for professionals in Regulatory Affairs. The role is located in Noida, Uttar Pradesh.
Job Overview
Job Title: Regulatory Affairs – CDSCO
Location: Noida, Uttar Pradesh
Employment Type: Full-Time
Experience Level: Entry to Mid-Level
Skills Required: Regulatory Compliance, CDSCO Registration, Medical Device Regulations, Documentation, Government Portal Applications
Key Responsibilities
As a Regulatory Affairs professional at Corpseed, your role will revolve around ensuring compliance with the regulatory standards set by the Central Drugs Standard Control Organization (CDSCO) and other applicable standards. Your core responsibilities will include:
- CDSCO Registration for medical devices, Drug & Cosmetics as per the rules and standards.
- Draft, review, submission and archival of other regulatory submissions (Query responses, corrections fillings, miscellaneous notifications regarding post registration regulatory lifecycle management) for Indian market.
- Candidates must know online application filing on Govt. websites. Review of technical documents before filing on CDSCO portal.
- Proper knowledge of Medical Device Rules 2017 and other ISO standards for medical device. Well aware with BIS registration, ISI/FMCS registration, BEE registration, WPC approval, FDA registration, Legal Metrology registration, Pollution NOC and Waste management compliance.
- Must know to handle/manage technical queries related to CDSCO (MD, Drug & Cosmetic) registration for client.
- Working experience in documentation required for quality certification. Knowledge of quality certification (ISI mark) of different products as per BIS norms Working experience in designing various testing machines as per Indian standards.
Qualifications and Skills
- Education: A degree in Pharmacy, Life Sciences, Biomedical Engineering, or a related field.
- Experience: Experience in regulatory affairs, preferably in medical devices or pharmaceuticals.
- Knowledge: Strong understanding of CDSCO regulations, medical device rules, and online submission processes.
How to Apply
Interested candidates can send their resumes to nitisha.kumari@corpseed.com with the subject line “Regulatory Affairs – CDSCO Application”. Make sure to highlight your experience in regulatory compliance and your expertise in medical device rules and CDSCO processes.
