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.
Are you looking for uncommon opportunities with an extraordinary company?
We are looking for people who can, do and will make a difference. Are you interested to hear more about this position?
To learn more about us, please visit: www.masimo.com
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