Regulatory Manager — EU

Position summary

This is not a traditional regulatory affairs role — the Regulatory Manager for the EU does not prepare or file Regara's own submissions. The role is the senior regional authority who owns Regara's regulatory coverage and credibility for the EU across three roughly equal pillars: leading training and QA of the AI on the EU, UK, and Switzerland frameworks, owning voice-of-customer for the region, and serving as senior content expert for go-to-market. The Manager sets the regional quality standard and develops the EU Specialist team.

Key responsibilities

• Own the quality and defensibility of Regara's AI outputs for EU regulatory pathways — setting the standard and the QA process.
• Lead training and QA of the platform on EU frameworks (the EMA, EU MDR (2017/745) and IVDR (2017/746), Notified Bodies and CE marking, EUDAMED, plus the UK MHRA/UKCA and Swissmedic), prioritizing what the AI must get right.
• Manage and develop the Regulatory Specialist(s) for the EU; set goals and standards.
• Own voice-of-customer for the EU, synthesizing regional RA needs into product and go-to-market.
• Serve as senior EU content expert supporting sales, marketing, and customer success (strategic deals, thought leadership, education).
• Define and maintain Regara's EU regulatory coverage roadmap with the product and AI teams.
• Monitor and interpret EU regulatory change; keep the platform and team current.
• Represent Regara's EU credibility externally with customers and at industry forums.
• Partner with the Director of Regulatory and peer regional managers to keep standards consistent globally.

Qualifications

Required

• 6+ years in regulatory affairs with deep EU expertise (the EMA, EU MDR (2017/745) and IVDR (2017/746), Notified Bodies and CE marking, EUDAMED, plus the UK MHRA/UKCA and Swissmedic), including senior or lead responsibility.
• Authoritative knowledge of EU submission pathways across device/IVD and/or pharma/biotech.
• Experience setting quality standards and, ideally, managing or mentoring others.
• Strong cross-functional leadership and customer-facing communication.
• Ability to work fully in office in Las Vegas.
• Bachelor's in a life science, engineering, or related field; advanced degree a plus.

Preferred

• EU regulatory certification and/or proficiency in a major European language such as German or French.
• Experience across multiple EU markets and product types.
• Experience in regulatory technology, consulting, or a software/AI environment.

What success looks like

Within the first year, Regara's EU regulatory coverage meets a defined quality bar, the EU specialist team is productive and developing, regional customers' needs shape the product, and Regara is credible in the EU market.