Job Description

The Senior Regulatory Affairs Manager will lead regulatory strategy and compliance activities across the EU, with a strong focus on enabling commercial success through effective tender participation and market access. This role requires deep expertise in EU MDR, CE marking, EUDAMED, and UDI, along with hands-on experience working with Notified Bodies and regulatory authorities.

The individual will act as a strategic partner to Commercial, Contracts, and cross-functional teams, providing regulatory insight to interpret complex tender requirements, identify compliance gaps, and develop practical solutions to win business. This role demands strong technical knowledge in EU labeling, eIFU, and promotional compliance, as well as the ability to implement processes, train teams, and translate evolving regulations into actionable business strategies.

A successful candidate will combine regulatory expertise, business acumen, and strategic thinking to drive compliant growth, ensure competitive positioning, and support sustainable expansion across European markets.

Duties & Responsibilities:

• Lead and execute regulatory strategy to support market access and commercial growth across Europe
• Drive regulatory support for tenders, including requirement review, gap analysis, and preparation of compliant documentation
• Partner with Commercial and Contracts teams to enable competitive, compliant, and timely tender submissions
• Manage CE marking, EU MDR compliance, and full product lifecycle activities (registrations, renewals, variations)
• Serve as primary interface with Notified Bodies and Competent Authorities for submissions, audits, and inspections
• Oversee setup and compliance of EU distributors, importers, and Authorized Representatives in accordance with MDR
• Ensure compliance with EUDAMED requirements, including actor registration, device registration, and vigilance data submissions
• Lead implementation and maintenance of UDI frameworks, ensuring compliance with EU MDR UDI requirements and alignment with global UDI systems (e.g., FDA, IMDRF)
• Act as SME for EU labeling, eIFU, and advertising/promotional (Ad/Promo) compliance
• Develop and maintain labeling procedures, governance, and training programs to ensure ongoing compliance
• Identify regulatory gaps and develop pragmatic solutions to meet tender and market requirements
• Translate evolving EU regulations into clear business actions and implementation plans
• Collaborate cross-functionally (Quality, Clinical, R&D, Supply Chain) to deliver regulatory outcomes
• Drive regulatory process improvements, system utilization (RIM/eQMS), and audit readinessDirect, plan, delegate and manage department budget and staff

Minimum experience:

• 8–12+ years of Regulatory Affairs experience in the medical device industry, with strong focus on EU regulations (EU MDR 2017/745)
• Proven experience with CE marking, Notified Body interactions, and EU regulatory submissions
• Hands-on experience with EUDAMED and UDI implementation, including alignment with global UDI frameworks
• Demonstrated experience supporting EU tenders, including regulatory documentation, gap assessments, and compliance strategies
• Experience with EU distributor, importer, and Authorized Representative setup and compliance
• Strong expertise in EU labeling, eIFU, and Ad/Promo compliance, including procedure development and training
• Solid knowledge of ISO 13485 and FDA QSR, with experience in international regulatory filings
• Strong cross-functional collaboration with Commercial, Contracts, Quality, and R&D teams
• Excellent communication, analytical, and problem-solving skills, with ability to translate regulatory requirements into business actions
• Self-driven, hands-on leader with strong execution focus, attention to detail, 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 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