MDR Specialist (Healthcare)

TL;DR

MDR Specialist (Healthcare): Managing regulatory compliance and certification processes for software medical devices within the Columna CIS electronic medical record platform with an accent on MDR and ISO 13485 standards. Focus on establishing technical files, conducting clinical evaluations, and collaborating with notified bodies to ensure product safety and regulatory alignment.

Location: Must be based in or able to travel to Aarhus, Denmark several times a week.

Company

hirify.global is a people-centric, international software company based in Denmark, developing innovative IT solutions for the healthcare sector and beyond.

What you will do

• Establish and maintain technical files for MDR components.
• Collaborate with customers and clinical experts on usability studies and clinical evaluations.
• Manage risks related to MDR and software medical device classifications.
• Advise project teams on regulatory activities and certification strategies.
• Plan and execute post-market surveillance activities.
• Support ISO 13485 certification processes and participate in ongoing quality audits.

Requirements

• Minimum 5 years of experience in a similar MDR specialist role.
• Extensive experience with software medical device classifications and technical file establishment.
• Strong background in ISO 13485, risk management, and regulatory approval of software.
• Fluent in Danish and English (written and spoken) is mandatory.
• Ability to work from the Aarhus HQ or travel there several times a week.

Culture & Benefits

• Access to an active Employees Club with nearly 100 social and professional events annually.
• On-site perks including physiotherapist-led massages, in-house hairdresser, and sports facilities.
• High-quality canteen serving healthy daily meals.
• Additional benefits such as free ARoS museum access and various shopping discounts.
• Professional environment with a focus on continuous development and innovation.