Hands-on Regulatory Affairs Expert

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.