QARA + SaMD Specialist

Aegan Technologies Hiring: QARA + SaMD Specialist (Contract Role)

Locations: Pune | Chennai | Bangalore | Mumbai | Hyderabad

Join Within: 15 Days

About the Role:

Aegan Technologies is looking for experienced QARA + SaMD (Software as a Medical Device) professionals for a contract-based opportunity. The ideal candidate will play a key role in ensuring regulatory compliance and software quality for global medical device markets.

Key Responsibilities:

• Develop and execute regulatory strategies for medical devices, including SaMD products, across global markets (FDA, EU MDR, etc.).
• Ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485, ISO 14971, IEC 62304, IEC 82304, and EU MDR requirements.
• Prepare regulatory submissions such as 510(k) and CE Mark documentation.
• Maintain and continuously improve Quality Management Systems (QMS) aligned with industry best practices.
• Manage Design History File (DHF) documentation including software design, verification, and validation activities.
• Lead and oversee risk management processes for SaMD and related medical device software.
• Collaborate with cross-functional teams including product development, clinical, and manufacturing during project execution.
• Stay current with regulatory updates and ensure timely implementation of new standards.
• Ensure usability compliance following IEC 62366 standards.

Required Experience:

• 3 to 10 years of experience in Medical Device QARA and Software Quality with direct exposure to SaMD projects.

Educational Qualification:

• Bachelor's degree or higher in any discipline (Engineering, Life Sciences, Biomedical, or related fields preferred).

Mandatory Skills:

• Strong expertise in Medical Device QARA and Software Quality (SaMD).
• Deep understanding of Design Controls, DHF, SDLC, Software Validation, and Digital Health Regulations.
• Proven experience with Regulatory Submissions and Audit Readiness.
• Excellent communication, documentation, and collaboration skills.

Preferred / Key Skills:

• QARA + SaMD
• Software as a Medical Device
• Software Quality
• IEC Standards (IEC 62304 & IEC 82304)
• AI-enabled SaMD

Interested Candidates Apply at - /

Job Type: Contractual / Temporary

Benefits:

• Health insurance
• Provident Fund

Work Location: In person