Senior Regulatory Affairs Specialist (MedTech)

TL;DR

Senior Regulatory Affairs Specialist (MedTech): Managing regulatory strategies and global device registrations for innovative software and intraoral scanner solutions with an accent on AI-based medical devices and digital health compliance. Focus on interpreting complex standards like IEC 60601, ISO 14971, and IEC 62304 to ensure market release success across global regions.

Location: Based in Copenhagen, Denmark (Hybrid: up to 2 days/week work from home).

Company

hirify.global is a global medical technology company developing award-winning 3D scanning and CAD/CAM solutions for dentistry and hearing healthcare.

What you will do

• Ensure regulatory compliance for medical device software and hardware portfolios including AI-powered devices.
• Provide strategic regulatory expertise for product development projects from the initial concept phase.
• Coordinate global device registrations and maintain documentation for markets including EU, UK, and Switzerland.
• Collaborate with cross-functional R&D, marketing, and product teams to integrate regulatory requirements.
• Represent the company in external industry organizations and influence regulatory policy frameworks.
• Support regulatory consultants and external advisors in ensuring global market access.

Requirements

• Master’s degree in natural sciences, computer science, engineering or related field.
• 5-10+ years of professional experience in regulatory affairs within the medical device sector.
• Strong background in global regulatory market requirements (EU, UK, Switzerland, MDSAP).
• Proven expertise in applying standards: IEC 60601, ISO 14971, IEC 62304, IEC 82304.
• Deep understanding of cybersecurity regulations for digital health and AI/ML medical devices.
• Ability to thrive in an agile work environment and work effectively across different cultures.

Culture & Benefits

• Attractive healthcare package provided.
• Daily breakfast and healthy lunch prepared by private chefs.
• Flexible work-life balance policy allowing up to 2 days of remote work per week.
• Modern office location in the heart of Copenhagen near Kongens Nytorv.
• Dynamic, international work environment with 50+ nationalities in the headquarters.
• Commitment to social team activities and employee well-being initiatives.