Hybrid Director, Quality Engineering – Regulatory Operations

at Velsera

• Job title: Director, Quality Engineering – Regulatory Operations
• Job type: Full Time
• Experience level: Lead
• Salary: Not specified
• Degree requirement: Postgraduate Degree
• Tech skills: SDLC
• Location requirements: Hybrid, Pune, India

About the role

• Director of Quality Engineering & Regulatory Operations at Velsera focusing on regulatory compliance and quality management systems in life sciences software. Responsible for maintaining inspection readiness and leading quality operations teams.

Responsibilities

• Own and continuously improve the ISO 13485-aligned Quality Management System (QMS), including document control, training, management review, CAPA, non-conformances, and quality metrics.
• Ensure inspection readiness and host FDA inspections, IVDR/MDR Notified Body audits, and customer quality audits.
• Operationalize regulatory requirements into engineering and operational processes, including design controls, risk management facilitation (ISO 14971), and IEC 62304-aligned SDLC governance.
• Maintain inspection-ready Design History Files (DHF), traceability, release, and change control processes.
• Establish and maintain a supplier quality and validation oversight program for critical vendors and service providers.
• Apply 21 CFR Part 11 and EU Annex 11 requirements pragmatically where applicable (regulated records, audit trails, e-signatures, validated workflows).
• Lead and scale a high-performing Quality Operations team.
• Partner with Information Security & GRC leadership under an Integrated Management System (IMS) governance model, sharing audit artifacts while preserving separation of duties.

Requirements

• 10+ years of experience in Quality / Regulatory Operations within regulated healthcare, SaMD, IVD, or life sciences software.
• Deep expertise in ISO 13485, FDA QMSR (21 CFR 820), IVDR/MDR, ISO 14971, and IEC 62304.
• Demonstrated ownership of audits, CAPA programs, and inspection readiness.
• Strong ability to operate effectively within an engineering-led organization.
• Preferred: Experience operating within an Integrated Management System (IMS).
• Working knowledge of enterprise security, privacy, and GxP expectations to support cross-functional audits.
• Experience scaling compliance in AI-driven or clinical genomics platforms.

Benefits

• Flexible Work & Time Off - Embrace hybrid work models and enjoy the freedom of unlimited paid time off to support work-life balance.
• Health & Well-being - Access comprehensive group medical and life insurance coverage, along with a 24/7 Employee Assistance Program (EAP) for mental health and wellness support.
• Growth & Learning - Fuel your professional journey with continuous learning and development programs designed to help you upskill and grow.
• Recognition & Rewards - Get recognized for your contributions through structured reward programs and campaigns.
• Engaging & Fun Work Culture - Experience a vibrant workplace with team events, celebrations, and engaging activities that make every workday enjoyable.
• & Many More...