Senior QMS & Regulatory Specialist

About the Role

We are seeking a SaMD QMS & Regulatory Expert to lead quality and regulatory activities with a specific focus on FDA compliance and IEC 62304 software lifecycle management. This role is central to ensuring that our Software as a Medical Device (SaMD) products meets all applicable U.S. FDA regulatory requirements while maintaining a robust, software-driven Quality Management System (QMS) that aligns with ISO 13485, ISO 14971 and FDAs requirements.

The ideal candidate will have deep expertise in software lifecycle documentation, design controls, risk management, verification/validation, and regulatory submissions for software-based medical devices.

The person should be someone who can take ownership and get things done with minimal training.

A minimum of 5+ years in the med tech industry is needed for this role.

Key Responsibilities

• Establish and maintain software development lifecycle (SDLC) documentation consistent with IEC 62304.
• Collaborate with R&D and product teams to define software classification, safety classes, and traceability between requirements, risks, tests, and defects.
• Lead design control activities, including software requirements specifications (SRS), design inputs/outputs, V&V protocols, and release records.
• Oversee software maintenance, configuration management, and problem resolution processes in compliance with IEC 62304.
• Prepare, review, and maintain Design History Files (DHF) and Device Master Records (DMR) in accordance with FDA and ISO standards.
• Ensure compliance with FDA guidance on SaMD, including:
• Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
• Cybersecurity in Medical Devices
• Support regulatory submissions by generating and reviewing documentation on risk management, software validation, cybersecurity, and usability.

Qualifications & Experience

• Bachelors or Master’s degree in Biomedical Engineering, Software Engineering, Regulatory Affairs, or Quality Management.
• 5–8 years of experience in medical device regulatory and quality roles, with significant exposure to SaMD.
• Deep understanding of:
• FDA 21 CFR Part 820 (QSR) / 21 CFR Part 11 (Electronic Records)
• IEC 62304 (Software Lifecycle Processes)
• ISO 14971 (Risk Management)
• ISO 13485 (QMS for Medical Devices)
• Proven experience preparing and maintaining FDA 510(k) or De Novo submissions for software devices.
• Strong familiarity with software V&V, design control, cybersecurity, and requirements traceability tools (e.g., Jira, Polarion, Greenlight Guru, Jama).
• Excellent communication, analytical, and technical writing skills.

Industry

• Software Development

Employment Type

Full-time

Immediate Joiner only.