Post Market Surveillance Manager (MedTech)

Location: Onsite in Copenhagen, Denmark, at the office near Kongens Nytorv.

Company

hirify.global develops 3D scanning and CAD/CAM solutions for the dental and healthcare industries, with more than 2,000 employees globally.

What you will do

• Lead and maintain the post-market surveillance program in accordance with EU MDR, FDA, ISO 13485, and other global requirements.
• Develop PMS plans, PMS reports, PSURs, PMCF reports, and trend analyses.
• Monitor complaints, adverse events, customer feedback, and other post-market data sources.
• Identify safety and performance trends and support risk management activities.
• Lead vigilance assessments and regulatory reporting for adverse events, serious incidents, and field safety corrective actions.
• Collaborate with Regulatory Affairs, Product Creation, Product Management, and other stakeholders to improve products and present findings to senior leadership.

Requirements

• Master’s degree in Life Sciences, Engineering, Biomedical Sciences, Public Health, Healthcare, or a related field.
• Relevant Quality, Regulatory, or Vigilance operational experience in the medical device industry.
• Knowledge of EU medical device regulations and directives, including ISO 13485 and ISO 14971.
• Strong planning, cooperation, communication, and stakeholder-management skills.
• Basic statistical knowledge and the ability to manage multiple tasks and tight deadlines.

Nice to have

• Basic AI knowledge, preferably involving tools used for PMS, vigilance, and trending.

Culture & Benefits

• Attractive office environment in downtown Copenhagen near Kongens Nytorv.
• Informal, social, diverse, and highly skilled working environment.
• Professional challenge in a dynamic, globally oriented MedTech business.
• Opportunity to influence and take ownership of assigned work.
• Collaboration with global internal stakeholders, resellers, and external consultants.