Executive - Regulatory Affairs | Leading Pharma MNC | Mumbai
HINDCO CONSULTING SERVICES · Chandigarh · onsite · Posted 34d ago
Undisclosed0–5 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
- Ensures compliance with MDR 2017 and global regulations.
- Manages CDSCO submissions, authority liaison, and core technical docs.
- Tracks regulatory updates; works with QA/R&D to enable safe market access for SaMD & implants.
- Knowledge of Medical Device Software (SaMD) regulations is a plus.
- Manages CDSCO submissions, authority liaison, and core technical docs.
- Tracks regulatory updates; works with QA/R&D to enable safe market access for SaMD & implants.
Required Candidate profile
- B.Pharm/M.Pharm with strong understanding of medical device regulations (India, EU, US).- Knowledge of Medical Device Software (SaMD) regulations is a plus.
Sourced from naukri
Skills
QADossierEMAclinical researchclinical trialsDrug safetyregulatoryRegulatory Affairsregulatory submissionsCase ProcessingCDSCOUSFDABiologicsRACTDSaMDMedical DevicesLegal DocumentationregulationsPharmaceuticalclinical evaluation reports
About HINDCO CONSULTING SERVICES
HINDCO CONSULTING SERVICES
25
employees
2003
23 years old
New Delhi, Delhi
India
₹2.8L PA avg
Avg at HINDCO CONSULTING SERVICES
About
Hiring for - A Multinational Automotive Premier leader in the automotive industry, offering a comprehensive one-stop solution that spans every aspect of the automotive business.
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