QARA Specialist - SaMD Focus

QualBizz is looking for Immediate joiners for its client. Email to hrindia@qualbizz.com

NO SaMD experience, DO NOT WASTE TIME sharing / applying.

3 years of experience with multiple positions.

Hybrid, Multiple Locations across India

CTC : <

10 LPA

Job Summary :

An experienced Quality Assurance and Regulatory Affairs (QARA) professional specializing in Med Device software quality, including Software as a Medical Device (SaMD). The ideal candidate will have 3 years of hands-on experience in regulatory strategy, quality systems, and compliance for digital health products and medical device software . This role is critical in ensuring our SaMD offerings meet global regulatory and quality standards across the product lifecycle .

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.
• Prepare regulatory submissions including 510(k), CE Mark.
• Maintain and improve Quality Management Systems (QMS) aligned with industry best practices.
• DHF documentation, including software design documents and verification / validation activities.
• Lead risk management processes.
• Collaborate with cross-functional teams,s including product development, clinical, and manufacturing during project executions.
• Stay updated on regulatory changes and ensure timely implementation.
• Experience with usability engineering and usability standards (IEC 62366)

Required Qualifications :