Hands-on Regulatory Affairs Expert
Sunmedic AB · Vellinge · Tills vidare · Deadline 2026-10-25
Sunmedic AB is seeking a **Hands-on Regulatory Affairs Expert** to take ownership of technical documentation and secure compliance for medical devices. The role involves preparing, maintaining, and updating technical files in line with EU MDR, managing regulatory submissions and lifecycle activities, and supporting the ISO 13485 quality management system. Working closely with R&D and Quality Assurance, the expert assesses design, labelling, and material changes, contributes to post-market surveillance reports such as PMCF and PSUR, and prepares documentation for notified body and competent authority audits. The employer offers **flexible working arrangements**. Candidates must hold a Bachelor’s or Master’s degree in Life Sciences, Engineering, or a related field, alongside at least **two years of hands-on regulatory affairs experience** in the medical device industry. Solid experience with technical files and ISO 13485 quality management systems is required, as well as a strong working knowledge of EU MDR requirements and regulatory submissions. Proficiency in written and spoken English is essential. Experience with post-market surveillance, clinical evaluation reports, US FDA 510(k) or UK MDR submissions, and previous participation in audits or inspections are advantageous.
Sunmedic is a medical device company focused on developing safe and effective products. We are looking for a hands-on Regulatory Affairs Expert who can take ownership of technical documentation, ensure regulatory compliance, and work closely with quality and development teams.
What you will do
- Prepare, maintain, and update technical files and regulatory documentation in line with EU MDR and other applicable regulations.
- Handle regulatory submissions (EU MDR) and manage lifecycle activities including updates and variations.
- Support and maintain the quality management system (ISO 13485), including quality control documentation and records.
- Review and assess design changes, labeling updates, and material changes for regulatory impact.
- Collaborate with Quality Assurance and R&D teams to ensure technical documentation is complete, accurate, and audit-ready.
- Prepare for and support audits and inspections by notified bodies and competent authorities.
- Contribute to post-market surveillance activities and the preparation of related reports (e.g., PMCF, PSUR).
- Monitor regulatory updates and implement necessary changes in technical files and quality documentation.
Who you are
- A practical and detail-oriented regulatory professional who enjoys working directly with technical files and documentation.
- Comfortable working in a fast-paced environment where you need to deliver concrete regulatory outputs.
- Proactive in identifying compliance gaps and implementing practical solutions.
- Clear communicator who can work effectively with Quality, R&D, and external auditors.
What you have
- Bachelor’s or Master’s degree in Life Sciences, Engineering, or a related field.
- At least 2 years of ,hands-on regulatory affairs experience, in the medical device industry.
- Solid experience preparing and maintaining, technical files, and working within a quality management system (ISO 13485).
- Good knowledge of EU MDR requirements and regulatory submissions.
- Strong organizational skills and attention to detail when managing documentation and multiple tasks.
- Proficiency in English (written and spoken).
Nice to have:
- Experience with post-market surveillance and clinical evaluation reports.
- Familiarity with US FDA 510(k) or UK MDR submissions.
- Previous involvement in audits or inspections.
What we offer
- Competitive salary and benefits.
- Flexible working arrangements.
- The opportunity to work closely with product development and quality teams on real regulatory deliverables.
How to apply
Please send your CV and a short cover letter describing your experience with technical files, quality systems, and regulatory submissions, to abbas.karladani@sunmedic.se. Mention any specific documentation or projects you have worked on.