Position: RA & QA Associate
Location:Delhi
Working Days:5 Days Monday - Friday Timings: 9:00 AM 5:00 PM
Responsible for regulatory submissions product registrations license renewals and compliance for medical devices in India and neighboring countries. Supports Quality Management System (QMS) audits CAPA supplier/distributor quality and ensures compliant labeling documentation and distribution practices in line with medical device regulatory requirements.
Key Responsibilities:
Prepare and manage regulatory submissions for medical device approvals renewals and change notifications.
Monitor and interpret CDSCO BIS EPR and other device-related regulations.
Maintain licenses certifications and regulatory documentation.
Support QMS implementation internal/external audits and CAPA processes.
Review and approve medical device labels artworks and promotional content.
Manage supplier/distributor quality and device complaint handling.
Coordinate with consultants government agencies and internal teams.
Masters in Pharmacy Biotechnology or Life Sciences.
25 years experience in RA & QA (Healthcare / Medical Device).
Knowledge of Indian FDA ISO 13485 and global regulatory norms.
Contract: 1 Year (Renewable).
Payroll: Talisman HR Solution.
Benefits: PF ESIC / Insurance Annual Leaves.
Future Scope: May be considered for on-roll role that is on Companies Payroll based on performance.
For more details visit: period auto-renewable or not: 1 year. Can be renewed with evaluation.
On Third Party Payroll (Talisman HR)
Interested can share updated cv on or Whats app :
Required Experience:
IC
Talisman HR Solutions Private Limited has come a long way since its inception in 2002. What started as a humble placement service ï¬rm has now evolved into one of the best HR Outsourcing companies in India. We specialize in Outsource Stafï¬ng, Payroll Processing, Recruitment, HR Out ... View more