Senior Regulatory Affairs Manager (Medtech)

TL;DR

Senior Regulatory Affairs Manager (Medtech): Leading regulatory strategy and compliance activities across the EU with an accent on tender participation, market access, and EU MDR compliance. Focus on managing CE marking, EUDAMED, and UDI frameworks while partnering with commercial teams to drive compliant growth and competitive positioning.

Location: Basingstoke, United Kingdom

Company

hirify.global is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, automation and connectivity solutions, devices, and sensors.

What you will do

• 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 documentation preparation.
• Manage CE marking, EU MDR compliance, and full product lifecycle activities.
• Serve as the primary interface with Notified Bodies and Competent Authorities for audits and submissions.
• Oversee compliance of EU distributors, importers, and Authorized Representatives.
• Lead the implementation and maintenance of UDI frameworks and EUDAMED requirements.

Requirements

• 8–12+ years of Regulatory Affairs experience in the medical device industry.
• Strong expertise in EU regulations, specifically EU MDR 2017/745.
• Proven experience with CE marking, Notified Body interactions, and EU regulatory submissions.
• Hands-on experience with EUDAMED and UDI implementation.
• Solid knowledge of ISO 13485 and FDA QSR.
• Bachelor’s degree in life sciences, engineering, law, medicine, or pharmacy.

Nice to have

• Experience in patient monitoring, digital health, or software-enabled medical technologies.
• 3–5+ years of people leadership or matrix leadership experience.
• Graduate degree in a technical discipline or business management.

Culture & Benefits

• Opportunity to work with a global leader in medical technology.
• Strategic role with significant impact on commercial success and market expansion.
• Collaborative environment working across Quality, Clinical, R&D, and Supply Chain teams.
• Focus on professional development and regulatory leadership.