Velsera

Director, Quality Engineering – Regulatory Operations

Velsera

full-time

Posted on:

Location Type: Hybrid

Location: Pune • India

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Job Level

Lead

Tech Stack

SDLC

About the role

  • 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...
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
ISO 13485FDA QMSR (21 CFR 820)IVDRMDRISO 14971IEC 62304CAPArisk managementdesign controlsquality metrics
Soft Skills
leadershipteam managementoperational effectivenesscollaborationcommunication