Sr Executive Medical Devices QARA

Perydot NexaTech Pvt. Ltd.; Navi Mumbai; On-site; INR 1,400,000 - 2,200,000; Full time

Job summary

Perydot NexaTech Pvt. Ltd. is seeking an experienced QARA professional with deep expertise in SaMD and medical device software quality.

The role focuses on regulatory strategy, quality systems, and ensuring global compliance across the product lifecycle. The ideal candidate will drive strategies for FDA, EU MDR, ISO 13485, and IEC standards, while overseeing post-market surveillance, CAPA, and risk management in collaboration with product, clinical, and manufacturing teams.

Qualifications

• 4–6 years of hands-on experience in regulatory strategy, quality systems, and compliance for digital health products and medical device software.

Responsibilities

• Develop and execute regulatory strategies for medical devices including SaMD across global markets (FDA, EU MDR).
• Ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485, ISO 14971, IEC 62304, IEC 82304, and EU MDR.
• Post Market Surveillance including complaints handling and CAPA, RCA.
• 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 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)

Skills

Regulatory strategy

Quality management

Compliance management

SaMD

Medical device software

Regulatory intelligence

Job description

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 4-6 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.
• - Post Market Survellience including complaints handling and CAPA, RCA
• - 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 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)

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.