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 [email protected]. Mention any specific documentation or projects you have worked on.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),…