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Regulatory Affairs Coordinator

Adxto AB
Stockholms län
för 1 vecka sedan

We are looking for a Regulatory Affairs Coordinator on behalf of a global pharmaceutical and medical device company. This is an opportunity to join a well-established organization with a strong commitment to quality and compliance across its portfolio!

In this role, you will support regulatory compliance activities for medical devices in several European markets. You will work with internal stakeholders to ensure product approvals, maintain regulatory systems and documentation, and contribute to the successful integration of new product lines.

You’ll be part of a high-performing, international team – where your analytical mindset, self-motivation, and strong sense of structure will be highly valued. We’re looking for someone who is adaptable, proactive, and a real problem solver. Someone who thrives in a fast-paced environment, communicates clearly, and is eager to learn and grow.

Responsibilities include:

  • Supporting pre-market regulatory activities such as documentation review and system updates
  • Managing and maintaining regulatory databases and product licenses
  • Collaborating cross-functionally with regulatory, commercial, and supply chain teams
  • Providing regulatory input to internal stakeholders including sales and marketing
  • Identifying and escalating regulatory concerns and assisting in developing solutions

Qualifications:

  • Degree in Life Sciences or related field (e.g. Pharmacy, Engineering, Biology, Chemistry)
  • Some experience in regulatory affairs or related roles is an advantage
  • Strong organizational skills and attention to detail
  • Fluency in English; additional European languages are a plus
  • Proficient in Excel and comfortable working in a fast-paced environment
  • Knowledge of EU MDR or national regulatory frameworks is beneficial


Location: Solna, Sweden
Start: As soon as possible
Employment type: Consultant assignment, 6 months


Does this sound like you? Don’t hesitate to apply – we’re reviewing applications on an ongoing basis.

We look forward to receiving your application!

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