SaMD and IVD Principal Manager
Takeda
3 months ago
Remote friendly (Lexington, MA)
United States
$116,000 - $182,270 USD yearly
Operations
OBJECTIVES / PURPOSE
- Execute Device Quality (DQ) activities supporting software medical devices (SaMD), in vitro diagnostics (IVD), and combination products across the product lifecycle (design, development, manufacturing, distribution, post-market).
- Ensure compliance with applicable quality and regulatory standards.
- Provide quality oversight/support for inspections, regulatory submissions/approvals, CAPA, complaint handling, and change control.
ACCOUNTABILITIES
- Represent Device Quality for medical device/combination product development initiatives throughout clinical development, design transfer, and commercialization.
- Own DQ deliverables including risk management documentation, quality plans, traceability matrices, and software validation for IEC 62304 Class A/B/C SaMD and IVDs.
- Ensure risk management deliverables (e.g., risk management plan, FMEA, hazard analysis, risk management report) and quality planning are completed for assigned projects.
- Maintain compliance with IEC 62304, IEC 61010, MDR, MDSAP, ISO 13485, ISO 14971, and other relevant global regulations/standards.
- Provide technical quality support for regulatory filings and design verification/validation for SaMD/IVDs.
- Serve as subject matter expert (SME) for assigned programs/products.
- Lead quality improvement initiatives and design enhancements within lifecycle management.
- Conduct quality assessments during supplier qualification.
- Support internal/external audits as SME for product lifecycle documentation.
- Lead commercial lifecycle management activities: change control, deviation investigations, CAPA, and complaint handling.
REQUIRED QUALIFICATIONS
- Bachelor’s degree in Engineering (or equivalent technical discipline) + at least 5 years in Quality Assurance/Quality Engineering for medical devices and/or combination products.
- Extensive knowledge of international device/combination product regulations: ISO 13485, MDSAP, ISO 14971, MDR, IEC 62304, 21 CFR Part 820.
- Experience with commercial development and regulatory filings.
- Proven ability to work with external manufacturing partners and lead root cause analysis/investigations.
- Strong operational background with GDPs, process efficiency, and turnaround time improvement.
- Experience collaborating with global cross-functional teams (project/program management and operational excellence preferred).
DESIRED QUALIFICATIONS
- Advanced degree.
- Biotech/device industry experience; medical device engineering background preferred.
- Familiarity with digital health solutions.
- Execute Device Quality (DQ) activities supporting software medical devices (SaMD), in vitro diagnostics (IVD), and combination products across the product lifecycle (design, development, manufacturing, distribution, post-market).
- Ensure compliance with applicable quality and regulatory standards.
- Provide quality oversight/support for inspections, regulatory submissions/approvals, CAPA, complaint handling, and change control.
ACCOUNTABILITIES
- Represent Device Quality for medical device/combination product development initiatives throughout clinical development, design transfer, and commercialization.
- Own DQ deliverables including risk management documentation, quality plans, traceability matrices, and software validation for IEC 62304 Class A/B/C SaMD and IVDs.
- Ensure risk management deliverables (e.g., risk management plan, FMEA, hazard analysis, risk management report) and quality planning are completed for assigned projects.
- Maintain compliance with IEC 62304, IEC 61010, MDR, MDSAP, ISO 13485, ISO 14971, and other relevant global regulations/standards.
- Provide technical quality support for regulatory filings and design verification/validation for SaMD/IVDs.
- Serve as subject matter expert (SME) for assigned programs/products.
- Lead quality improvement initiatives and design enhancements within lifecycle management.
- Conduct quality assessments during supplier qualification.
- Support internal/external audits as SME for product lifecycle documentation.
- Lead commercial lifecycle management activities: change control, deviation investigations, CAPA, and complaint handling.
REQUIRED QUALIFICATIONS
- Bachelor’s degree in Engineering (or equivalent technical discipline) + at least 5 years in Quality Assurance/Quality Engineering for medical devices and/or combination products.
- Extensive knowledge of international device/combination product regulations: ISO 13485, MDSAP, ISO 14971, MDR, IEC 62304, 21 CFR Part 820.
- Experience with commercial development and regulatory filings.
- Proven ability to work with external manufacturing partners and lead root cause analysis/investigations.
- Strong operational background with GDPs, process efficiency, and turnaround time improvement.
- Experience collaborating with global cross-functional teams (project/program management and operational excellence preferred).
DESIRED QUALIFICATIONS
- Advanced degree.
- Biotech/device industry experience; medical device engineering background preferred.
- Familiarity with digital health solutions.