SaMD and IVD Principal Manager

Role Summary

The SaMD and IVD Principal Manager is an experienced quality and technical professional responsible for executing activities within the Device Quality function to support software medical devices (SaMD), in vitro diagnostics (IVD), and combination products across all phases of the product lifecycle—design, development, manufacturing, distribution, and post-market support. This role ensures compliance with applicable quality and regulatory standards and provides quality oversight for inspections, regulatory submissions and approvals, CAPA, complaint handling, and change control processes.

Responsibilities

• Represent Device Quality in support of Takeda’s medical device and combination product development initiatives throughout clinical development, design transfer, and commercialization.
• Own DQ deliverables such as risk management documentation, quality plans, traceability matrices, and software validation for IEC 62304 Class A, B, and C SaMD and IVDs.
• Ensure risk management deliverables (risk management plan, FMEA, hazard analysis, risk management report) and quality planning activities are completed for assigned projects.
• Maintain compliance with IEC 62304, IEC 61010, MDR, MDSAP, ISO 13485, ISO 14971, and other relevant global regulations and standards.
• Provide technical quality support for regulatory filings and design verification/validation activities for SaMD and IVDs.
• Act as subject matter expert (SME) for assigned programs and products.
• Lead quality improvement initiatives and design enhancements within lifecycle management of assigned devices and combination products.
• Conduct quality assessments during supplier qualification for assigned development projects.
• Support internal and external audits, serving as SME for product lifecycle documentation.
• Lead and execute commercial lifecycle management activities, including change control, deviation investigations, CAPA, and complaint handling.

Qualifications

• Required: Bachelor’s degree in Engineering or equivalent technical discipline, plus at least 5 years of experience in Quality Assurance or Quality Engineering roles for medical devices and/or combination products.
• Required: Extensive knowledge of international regulations for devices and combination products, including ISO 13485, MDSAP, ISO 14971, MDR, IEC 62304, and 21 CFR Part 820.
• Required: Experience with commercial development and regulatory filings.
• Required: Proven ability to work with external manufacturing partners, conduct root cause analysis, and drive effective investigations.
• Required: Strong operational background with expertise in GDPs, process efficiency, and turnaround time improvement.
• Required: Experience collaborating with global cross-functional teams; project/program management and operational excellence preferred.
• Preferred: Advanced degree.
• Preferred: Experience in the biotech/device industry; medical device engineering background preferred.
• Preferred: Familiarity with digital health solutions.

Skills

• Strong scientific and technical expertise to analyze complex product data and make sound, risk-based quality decisions.
• Ability to ensure compliance of commercial and clinical devices and combination products for global markets, including timely completion of vigilance assessments, investigations, incident escalation, and CAPA activities.
• Demonstrated ability to build authentic relationships, foster trust, and collaborate effectively as a team leader or member.
• Skilled in constructive challenge, clear communication, and delivering results through teamwork.
• Strong decision-making skills, even under uncertainty; drive continuous improvement to mitigate risks and maintain effective operations.
• Ability to work productively within cross-functional teams and build relationships with Device Quality partners and global process owners.
• Analytical mindset to identify and implement process improvements.
• Ability to navigate ambiguity while making quality decisions, assessing performance, and driving change.

Education

• Bachelor’s degree in Engineering or equivalent technical discipline
• Advanced degree (preferred)