Job Summary:
The Senior Manager, Quality & Regulatory Operations will lead regulatory and quality operations to support compliance, market access, and commercial success. This role combines regulatory expertise with quality systems leadership to ensure products, processes, and documentation meet EU and global requirements.
The individual will act as a key partner to Commercial, Contracts, and cross-functional teams to support tender readiness, interpret regulatory and quality requirements, identify gaps, and implement practical solutions. This role requires strong expertise in medical device regulatory frameworks, quality systems, labeling, and post-market compliance, along with the ability to drive operational excellence and audit readiness.
Duties & Responsibilities:
- Lead RA/QA operations strategy and execution to support compliance and business growth
- Drive regulatory and quality support for tenders, including requirement review, gap assessment, and compliant documentation
- Partner with Commercial and Contracts teams to enable timely and competitive tender submissions
- Ensure compliance with applicable global regulatory and quality requirements
- Ability to interface with Notified Bodies and Competent Authorities for audits, inspections, and compliance activities
- Oversee EUDAMED compliance (actor registration, device data, vigilance) and support maintenance of regulatory records
- Support implementation and maintenance of UDI frameworks, ensuring alignment with EU and global UDI requirements
- Manage and improve Quality Management System (QMS) processes, including CAPA, change control, deviations, and audit readiness
- Provide oversight and guidance on regulatory submissions and lifecycle activities, with working knowledge of submission requirements (no direct ownership required)
- Oversee setup and compliance of distributors, importers, and Authorized Representatives
- Act as SME for labeling, eIFU, and Ad/Promo compliance, ensuring alignment with regulatory and quality standards
- Develop and implement policies, procedures (SOPs), and training programs for regulatory and quality compliance
- Identify regulatory and quality gaps and implement practical, compliant solutions to support business objectives
- Translate regulatory and quality requirements into clear operational processes and business actions
- Collaborate cross-functionally (Quality, Clinical, R&D, Supply Chain) to ensure alignment and execution
- Drive continuous improvement, inspection readiness, and effective use of systems (RIM/eQMS)
- Lead, mentor, and develop team members, while driving accountability and execution
Minimum experience:
- 8–12+ years of experience in Regulatory Affairs and/or Quality Assurance within the medical device industry
- Strong knowledge of EU MDR (2017/745), CE marking requirements, and European regulatory frameworks
- Hands-on experience with EUDAMED and UDI implementation in alignment with global frameworks
- Strong experience in Quality Management Systems (ISO 13485), including CAPA, audits, change control, and compliance processes
- Experience with EU distributor, importer, and Authorized Representative compliance
- Strong expertise in EU labeling, eIFU, and Ad/Promo compliance, including procedural development and training
- Excellent communication, analytical, and problem-solving skills, with ability to translate requirements into operational execution
Self-driven leader with strong attention to detail, execution focus, and ability to manage multiple priorities
Preferred experience:
- Experience in patient monitoring, hospital-based medical devices, digital health, or software-enabled medical technologies
- 3–5+ years of people leadership or matrix leadership experience, including mentoring and influencing cross-functional teams
- Experience working in EU-focused or global medtech organizations with exposure to multi-country quality and regulatory operations
- Demonstrated ability to support commercial/tender strategy and business growth initiatives through regulatory leadership.
Education:
Bachelor’s degree is required, preferably in life sciences, engineering, law, medicine, pharmacy, or another relevant scientific discipline. Graduate degree in a technical discipline or business management is preferred.
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To learn more about us, please visit: www.masimo.com
Skills Required
- 8-12+ years of Regulatory Affairs experience in medical device industry
- Strong focus on EU regulations (EU MDR 2017/745)
- Proven experience with CE marking and EU regulatory submissions
- Hands-on experience with EUDAMED and UDI implementation
- Experience with EU distributor and Authorized Representative compliance
- Strong expertise in EU labeling and Ad/Promo compliance
Masimo Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Masimo and has not been reviewed or approved by Masimo.
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Healthcare Strength — Comprehensive medical, dental, and vision coverage is offered alongside company‑paid life insurance at 2x salary and long‑term disability coverage. The package reflects broad core health protection.
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Leave & Time Off Breadth — Policies include 15 days of paid vacation to start, up to 10 paid holidays, 40 hours of sick time, and defined paid parental leave components. This structure provides clear, multi‑category time‑off coverage.
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Wellbeing & Lifestyle Benefits — An EAP, corporate discounts, and onsite amenities such as a café, wellness center, and gym are available at certain locations. These perks enhance day‑to‑day support where onsite access exists.
Masimo Insights
What We Do
Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is to improve life, improve patient outcomes, reduce the cost of care, and take noninvasive monitoring to new sites and applications. Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown to outperform other pulse oximetry technologies in over 100 independent and objective studies, which can be found at www.masimo.com/evidence/featured-studies/feature. Masimo SET® is estimated to be used on more than 200 million patients around the world each year and is the primary pulse oximetry at all 10 top U.S. hospitals as ranked in the 2025 Newsweek World’s Best Hospitals listing. Additional information about Masimo and its products may be found at www.masimo.com.
