QA RA Lead - Medical Device

Careernet

5 - 10 years

9 - 17 Lacs

Bengaluru

Posted:2 weeks ago| Platform:

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Skills Required

CDSCO EU FDA ISO 13485 Regulatory Affairs IEC 60601 Device Registration Quality Assurance

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Architect and implement a lean, auditready
ISO13485:2016
Quality Management System and drive certification.
Own all designcontrol documentation (SRS, DHF, Risk Management File, DMR, Technical File, etc.) in collaboration with engineering teams.
Define and execute
regulatory strategies: first CDSCO (ClassII/III), then FDA 510(k), and EU MDR CE Mark.
Prepare, review, and submit regulatory dossiers; interact with authorities and notified bodies.
Plan and conduct internal audits, manage CAPA investigations, and lead continuousimprovement initiatives.
Qualify and monitor suppliers/CMOs; establish incoming and inprocess quality controls and batchrelease records.
Train crossfunctional teams on standards, good documentation practices, and change control.
Set up postmarket surveillance, complaint handling, and vigilance procedures ahead of launch.

Preferred candidate profile

Bachelors degree in engineering, Life Sciences, or related field; ISO13485 internalauditor certification preferred.
5 –10years’ QARA experience with ClassII (or higher) medical devices, ideally in a startup/smallteam environment.
Demonstrated handson implementation of ISO13485 and compilation of CDSCO dossiers or FDA/CE submissions.
Working knowledge of ISO14971, IEC62304, IEC60601, and Indian MDR2017; familiarity with EU MDR and 510(k) processes.
Strong documentation skills, analytical mindset, and ability to translate regulatory language into actionable tasks for engineers.
Selfstarter who thrives with minimal supervision and juggles multiple priorities in a fastmoving startup.

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