Executive QA/RA
4 days ago
We, at
BioTalent Search
, are hiring the
right candidate on behalf of our esteemed client
in the Medical Device Industry.
Position:
Executive – Quality Assurance / Regulatory Affairs (2)
Location:
Daman/ Khopoli
Experience:
5- 7 Years
Qualification:
B.Pharm / M.Pharm (Must have relevant experience in the Medical Device Industry)
Key Responsibilities:
- Ensure compliance with
ISO 13485, MDD, MDR, GMP, GDP, and QMS
requirements. - Coordinate with
local FDA and CDSCO
for obtaining required permissions and approvals. - Oversee
risk management, clinical evaluation, and post-market surveillance (PMS)
for Class Is, II, and Class III medical devices. - Manage
regulatory submissions
and ensure timely approvals. - Handle
Corrective and Preventive Actions (CAPA)
to maintain compliance and continuous improvement. - Support audits, inspections, and ensure readiness for regulatory authority reviews.
Candidate Profile:
- Strong understanding of
quality systems and regulatory frameworks
for medical devices. - Hands-on experience with
regulatory submissions, PMS, and risk management
. - Excellent knowledge of
GMP, GDP, and ISO 13485 standards
. - Strong communication, documentation, and coordination skills.
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