Lead - QARA

Key Responsibilities:

Regulatory and Compliance Oversight:

• Ensure the software complies with global regulations related to medical devices (FDA, EU MDR, HIPAA, etc.).
• Stay updated with FDA regulations, especially those relevant to MLMD (machine learning-enabled medical devices).
• Collaborate with cross-functional teams (development, testing, legal) to ensure regulatory requirements are integrated into the SDLC.

Software Development Lifecycle (SDLC) Management:

• Lead the regulatory and compliance aspects of the SDLC for the fertility-tracking product line.
• Ensure alignment with ISO 13485 (Quality Management Systems for Medical Devices), IEC 62304 (Software Lifecycle for Medical Devices), and ISO 14971 (Risk Management).
• Develop and maintain processes for risk management, traceability, and testing during software development.
• Oversee and sometimes contribute to the creation and maintenance of critical documentation like Software Requirements Specifications (SRS), Traceability Matrix, and Risk Analysis Matrix.

Technical Writing:

• Manage a team of technical writers responsible for generating detailed software documentation in compliance with regulatory standards.
• Collaborate with software developers, testers, and regulatory bodies to ensure documentation is accurate and thorough.
• Review and approve documents related to the SDLC, ensuring they meet quality and regulatory requirements.
• Write and update technical documents (SRS, Traceability Matrix, Risk Analysis) to support the team.

Regulatory Audits & Submissions:

• Prepare the company for regulatory audits and ensure all documentation is audit-ready.
• Liaise with regulatory bodies (FDA, EU, etc.) to ensure smooth submission processes for approvals and certifications.

Qualifications:

• Bachelors or Masters in Engineering, Software Development, Quality Assurance, or a related field.
• 8+ years of experience in quality assurance, regulatory compliance, or a similar role in the medical device or healthcare software industry.
• Proven experience with FDA and EU MDR /EU IVDR regulations, especially for SiMD (Software in Medical Devices) and MLMD (machine learning-enabled medical devices).
• Hands-on experience with EN ISO 13485, ISO 14971, and IEC 62304.
• Technical writing experience related to medical devices and software compliance is essential.

Note: Only shortlisted candidates will be contacted