Executive QA/RA

4 days ago

Khopoli, India BioTalent Search® Full time

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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