About us:
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.
About the role:
GO-Pen ApS is looking for a Regulatory Affairs and Quality Assurance Student Assistant with passion for structure and quality. You will be guided into the GO-Pen Quality Management System (QMS) by the RA/QA Director and experienced consultants, learn how to maintain the system and over the time take over the responsibility of the system. You will be working alongside the RA/QA Director to develop and maintain files for the different configurations of the GO-Pen product. The candidate will also be involved regulatory affairs processes of the products for approvals and maintanence of files in different target markets. If you are eager to learn and grow with a dynamic company and ready to take on a new challenge, we want to hear from you.
Responsibilities:
The main responsibilities will include assisting in the following:
- 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
With training over time:
- 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
Candidate Requirements:
The ideal candidate will have:
- 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
This is an on-site position, 15-20 hours per week on average.
We don’t believe in the perfect candidate because we value people who evolve and adapt quickly. If you think you could be a good fit, please apply.
We strongly encourage you to apply if you are part of a marginalized or underrepresented group, particularly in the technology industry. We encourage people of all races, ethnicities, religions, national origins, genders, sexual orientations, gender identities, and ages, as well as differently abled individuals to apply.
Start date – 17 August 2026
Please apply by sending your CV to Aparajita Tatke by latest 31 July 2026 at:
aparajita@go-pen.com
You are welcome to contact Aparajita with any questions you may have regarding the role.
We are looking forward to getting in touch!
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