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Student Assistant - Regulatory Affairs and Quality Assurance

Denmark, København · Job Posted July 04, 2026
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Job Description

GO-Pen ApS is a Danish medical device startup company that's revolutionizing the way people access affordable and safe medical devices. We are dedicated to developing innovative and affordable solutions that can benefit everyone - from low-income communities to the middle class. Our first product is for diabetes, where we have developed an affordable insulin pen. The product is FDA 510(k) cleared and CE marked. GO-Pen ApS was founded in 2019 by Ole and Michael who both have +20 years’ experience from the MedTech and pharmaceutical industry. We are a lean and passionate team with a strong network, contracting and working with the best in the industry. We value diversity – in backgrounds and experiences. We are developing medical devices intended to reach people of all backgrounds and identities from around the world. We hope to build a team that reflects that diversity.

Job Responsibility

  • Daily maintenance of the Quality Management System (QMS)
  • Coordination of engineering changes and non-conformities, handling CAPAs
  • Handling customer complaints and post market surveillance
  • Participating in quality meetings
  • Assisting and participating in internal audits, over time leading the internal audits
  • Preparation for management reviews
  • Supporting the team to ensure that global sustainability impact aspirations are met
  • Update and review of the SOPs
  • Training of GO-Pen employees in the QMS
  • Writing technical file documents
  • Regulatory file preparation of regulatory documents for various markets, including but not limited to USA, Europe, Mexico, South Africa, etc.
  • Management and collaboration of consultants assisting in market-specific regulatory submissions
  • Lead person responsible during visits from regulatory authorities
  • PRRC (Person Responsible for Regulatory Compliance) including: the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released
  • the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date
  • the post-market surveillance activities are implemented and maintained
  • Vigilance reporting including trend reporting, incident reporting, communication with National Authorities and Notified Body follow ups

Requirements

  • At least 1 year remaining in a Master’s degree in pharmaceutical sciences or healthcare area
  • Structured and detail-oriented approach. A strong attention to detail is required for this role
  • Excellent communication, motivation, and interpersonal skills, with the ability to be persistent if needed
  • Strong organizational skills, with the ability to manage multiple tasks and priorities effectively
  • Passion for and commitment to the company's mission and values
  • Fluent in English, Spanish is a plus but not a requirement
  • Previous experience in a similar role (RA/QA) would be preferred, but is not a requirement

Nice to have

  • Spanish is a plus but not a requirement
  • Previous experience in a similar role (RA/QA) would be preferred, but is not a requirement

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