Job OverviewThe Senior Manager,
R&D Product Excellence is responsible for leading a multidisciplinary team responsible for Design Assurance, Risk Management, Verification & Validation (V&V), Product Stewardship, Document Control, Labeling, Compliance, CAPA, and Complaint Management activities across the product lifecycle. This role ensures that products are developed, maintained, and commercialized in compliance with applicable global regulatory requirements and quality standards while supporting business objectives, patient safety, product quality, and continuous improvement.
The position provides strategic and operational leadership for quality and compliance activities throughout new product development, sustaining engineering, post-market surveillance, and lifecycle management. The Senior Manager partners closely with Quality, Regulatory Affairs, Operations, Manufacturing, Supply Chain, Clinical Affairs, and Commercial teams to ensure robust quality systems and effective execution of Design Control requirements.
Job Responsibilities and Essential DutiesDesign Assurance- Lead Design Assurance activities throughout the product lifecycle, ensuring compliance with Design Control regulations and quality system requirements.
- Provide quality leadership and oversight for new product development, sustaining engineering, and product lifecycle management projects.
- Ensure design inputs, outputs, verification, validation, and design transfer activities comply with applicable regulatory requirements.
- Participate in design reviews and provide independent quality oversight of development projects.
- Ensure Design History Files (DHF), Technical Files are complete, compliant, and inspection-ready.
Risk Management- Lead implementation and maintenance of product risk management processes in accordance with ISO 14971.
- Ensure risk analyses are performed, maintained, and updated throughout product development and post-market activities.
- Facilitate risk assessments for design changes, field actions, CAPAs, complaints, supplier issues, and manufacturing changes.
- Ensure linkage and traceability between hazards, risks, mitigations, verification evidence, and post-market surveillance data.
- Ensure robust root cause investigations utilizing structured problem-solving methodologies.
Verification & Validation (V&V)- Oversee development and execution of verification and validation strategies for new products and product modifications.
- Ensure V&V activities adequately demonstrate product safety, performance, reliability, and regulatory compliance.
- Review and approve protocols, reports, test strategies, and acceptance criteria.
- Ensure traceability between requirements, risk controls, and verification evidence.
Product Stewardship- Lead product stewardship programs to ensure ongoing product quality, safety, reliability, compliance, and customer satisfaction.
- Monitor post-market product performance metrics, complaint trends, field feedback, and quality data.
- Partner with Operations to drive continuous product improvement initiatives.
- Support lifecycle management, product refreshes, obsolescence management, and end-of-life planning.
- Lead Complaint management from R&D functionality point of view.
Document Control- Lead document control processes and governance for quality records and controlled documents.
- Ensure compliance with document management procedures and electronic quality management systems.
- Maintain oversight of controlled documentation including procedures, specifications, design documentation, protocols, reports, and labeling.
- Drive continuous improvements in documentation processes, efficiency, and compliance.
Labeling Compliance- Ensure product labeling, Instructions for Use (IFU), artwork, promotional claims, and product identifiers comply with applicable global regulations and standards.
- Review and approve labeling changes associated with product, regulatory, manufacturing, and quality system updates.
- Collaborate with Regulatory Affairs, Marketing, Clinical Affairs, and Quality to ensure labeling accuracy and compliance.
- Maintain oversight of UDI, regional labeling requirements, translations, and labeling controls.
R&D CAPA Management- Lead the CAPA process to ensure effective identification, investigation, correction, and prevention of quality issues.
- Ensure robust root cause investigations utilizing structured problem-solving methodologies.
- Monitor CAPA effectiveness and timeliness to ensure compliance with quality system requirements.
- Drive continuous improvement initiatives based on CAPA trends and quality metrics.
- Provide leadership during audits and inspections involving CAPA processes.
Complaint Management- Lead complaint handling activities in compliance with FDA, MDR, and global regulatory requirements.
- Ensure timely investigation, trending, escalation, and closure of product complaints in conjunction with Quality and other functions.
- Partner with Regulatory Affairs on reportability assessments, vigilance reporting, MDR submissions, and field actions.
- Monitor complaint data and post-market surveillance information to identify emerging quality and safety signals.
- Drive initiatives to improve customer experience and product quality through effective complaint analysis.
Compliance & Quality Systems- Ensure compliance with FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, EU MDR, MDSAP, IEC 60601, IEC 62304, and other applicable standards.
- Support internal audits, external audits, notified body audits, supplier audits, and regulatory inspections.
- Drive quality culture, compliance excellence, and continuous improvement throughout the organization.
- Develop departmental goals, metrics, budgets, strategic plans, and resource allocation.
- Lead and develop high-performing teams while fostering employee engagement and growth.
Minimum Requirements- Bachelor's degree in Engineering, Life Sciences, Technical Quality, Regulatory Affairs, or related technical discipline.
- Master's degree preferred.
- 10+ years of experience in medical device R&D, design assurance, or regulatory compliance.
- Minimum 5 years of progressive leadership or management experience.
- Demonstrated experience supporting Class II and/or Class III medical devices.
- Experience with new product development and post-market quality systems.
- Proven experience with Design Controls, Risk Management, V&V, CAPA, Complaint Handling, and Regulatory Compliance programs.
Required Knowledge, Skills, and Abilities- Deep knowledge of FDA Quality System Regulation (21 CFR Part 820/QMSR), ISO 13485, EU MDR, MDSAP, IEC 60601, IEC 62304, and ISO 14971.
- Strong understanding of quality systems, design controls, post-market surveillance, and product lifecycle management.
- Expertise in risk management methodologies and complaint/CAPA investigations.
- Experience leading verification and validation activities for medical devices.
- Knowledge of labeling regulations, UDI requirements, and global product registration processes.
- Strong analytical, technical, and problem-solving skills.
- Excellent verbal, written, presentation, and negotiation skills.
- Proven ability to influence and lead cross-functional teams.
- Strong project management and organizational abilities.
- Experience with electronic Quality Management Systems (eQMS), PLM, and document management systems.
Salary range: $190k -$215K; Target bonus 25%
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