Senior Regulatory Affairs Specialist at A3P Biomedical

Senior Regulatory Affairs Specialist at A3P Biomedical

A3P Biomedical is a Swedish diagnostics company specializing in advanced prostate cancer diagnostics. Our main product, Stockholm3, is a blood test for early detection of aggressive prostate cancer - with the potential to radically improve diagnostics and reduce mortality in one of the world's most common cancers. We are currently active in Switzerland, Germany, the UK, the US, Austria, Poland, Turkey, Sweden, Norway, and Finland.

To strengthen our Quality & Regulatory Affairs team, we are looking for a Senior Regulatory Affairs Specialist to join us. You'll be part of a small, dedicated team with direct responsibility for maintaining regulatory compliance for Stockholm3 throughout its product lifecycle, while supporting the company's continued growth and international expansion. This is a role for someone who enjoys combining strategic and operational work, takes ownership naturally, and wants their day-to-day work to make a real difference in patients' lives.

Your responsibilities

Develop and maintain regulatory strategies for Stockholm3 throughout its product lifecycle

Prepare, review, and maintain Technical Documentation in accordance with IVDR and applicable standards

Coordinate regulatory submissions and communication with Notified Bodies and Competent Authorities

Assess the regulatory impact of product changes and support change management activities

Support Performance Evaluation documentation and regulatory assessments in accordance with IVDR

Lead and maintain Post-Market Surveillance (PMS) activities, including PMS Plans and PMS Reports

Monitor changes in regulatory requirements and ensure continued compliance

Act as the company's regulatory subject matter expert, providing guidance and support across the organization

Participate in internal and external audits and contribute to the continuous improvement of the Quality Management System

Working hours

Full-time.

Required qualifications

MSc (or equivalent) in Life Sciences, Biomedical Engineering, Pharmacy, Biotechnology, or another relevant scientific discipline

At least five years of experience within Regulatory Affairs in the medical device or in vitro diagnostics industry

Solid knowledge of IVDR (EU 2017/746) and ISO 13485

Experience preparing and maintaining Technical Documentation

Experience working with Notified Bodies and Competent Authorities

Experience with Post-Market Surveillance and regulatory lifecycle management

Experience with Software as a Medical Device (SaMD) regulatory requirements

Excellent medical and scientific writing skills

Strong command of English, written and spoken

Meriting qualifications

Experience with FDA regulations and international regulatory submissions

What we're looking for in you

You're proactive, structured, and solution-oriented, with strong analytical skills and an eye for detail. You work well independently but collaborate easily across the organization, communicate clearly, and build strong professional relationships. You take pride in seeing things through - from planning to implementation - and you thrive in a dynamic environment where priorities can shift.

At A3P Biomedical, you'll join an ambitious, entrepreneurial team with a global mission: improving men's health and transforming prostate cancer diagnostics. Your work will have direct clinical impact. If you want to be part of a growing company that values collaboration, curiosity, and quality, we'd love to hear from you.

Learn more about us at A3P Biomedical.

Submit your application in English no later than 10 September. Selection and interviews are held continuously, so don't wait to apply - the position may be filled before the deadline.

This position is based in Stockholm or Uppsala, Sweden.