Director, Quality Engineering & Regulatory Operations

About Velsera

Medicine moves too slow. At Velsera, we are changing that.

Velsera was formed in 2023 through the shared vision of Seven Bridges and Pierian, with a mission to accelerate the discovery, development, and delivery of life-changing insights.

Velsera provides software and professional services for:

• AI-powered multimodal data harmonization and analytics for drug discovery and development
• IVD development, validation, and regulatory approval
• Clinical NGS interpretation, reporting, and adoption

With our headquarters in Boston, MA, we are growing and expanding our teams located in different countries!

In the absence of a standalone Regulatory Affairs organization, this role owns regulatory operations and inspection readiness, while regulatory strategy, submissions, and external commitments remain with executive leadership. Information Security and GRC are intentionally separate to preserve independence and audit credibility.

• 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.

Explicitly Out of Scope:

• Regulatory strategy, submission planning, and formal agency correspondence ownership.
• Security control ownership, SOC 2 attestation, or ISO 27001 certification ownership.

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.

• 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...