Regulatory Affairs Specialist
We are currently looking for a Regulatory Affairs Specialist (Medical Device Software).
Qaelum NV is one of the worldwide market leaders in dose management software. As a fast-growing medical software solutions provider, we are caring about patient safety and quality improvement in medical imaging departments. Started as a start-up of the University Hospitals of Leuven, Belgium, Qaelum is now the preferred choice for many major institutions all over the globe. We believe it is our mission to help all stakeholders, no matter what level they are at, in creating patient safe and optimized healthcare environments.
As we expand our global presence, we are seeking a dynamic and detail-oriented Regulatory Affairs Specialist to join our team.
Your responsibilities and tasks
- Global Regulatory Submissions:
- Manage the regulatory submission process for our medical device software in countries worldwide, with a focus on regions outside Europe.
- Stay abreast of international regulatory requirements and ensure timely and compliant submissions.
- Collaboration with Local Representatives and Partners:
- Establish and maintain effective communication with local country representatives and distribution partners to navigate regulatory landscapes and obtain necessary approvals.
- Work collaboratively to address country-specific requirements and ensure successful product registrations.
- Conversion of Legislation to Device Requirements:
- Convert country-specific legislation into actionable compliance requirements for our medical device software.
- Identify risks within regulatory strategies and clearly communicate risks to management.
- Collaborate with cross-functional teams within Qaelum to implement necessary changes to meet regulatory standards.
- Quality and Information Security (longer run):
- Contribute to the maintenance of the company's Quality Management System (ISO13485) and/or Information Security Management System (ISO27001).
- Assist in audits and inspections, ensuring compliance with regulatory standards.
- Continuous Learning:
- Demonstrate an eagerness to learn and adapt to evolving regulatory landscapes and industry standards.
- Stay informed about emerging trends and regulatory updates affecting medical device software.
- Bachelor's degree in a relevant field (Regulatory Affairs, Life Sciences, Engineering, etc.).
- Proven (first) experience in regulatory affairs for medical devices, with a focus on global submissions.
- Familiarity with ISO13485 and ISO27001 standards is a plus
- Strong analytical and problem-solving skills.
- Excellent communication and collaboration abilities.
- Detail-oriented with a commitment to maintaining high-quality standards.
You communicate fluently in English, both written and verbal (the knowledge of Dutch or other languages is a great asset) and love to learn and improve. What does it for us, is your drive and your intrinsic will to take initiative and ownership. We encourage a diverse environment where people are motivated to learn and to grow with the company. We hire people based on their skills and merit no matter their gender, age, location, or background.
How we support you
We provide an internationally oriented working atmosphere in which a team of professionals is dedicated to improving quality in medical imaging environments. Together we build on the next generation of quality improvements in healthcare. You will enjoy the freedom and responsibilities that a young fast-growing company like ours can bring to the table. As we also attach great importance to a sound work-life balance and life-long learning, we provide flexible working hours, a home-office working balance, and every opportunity to take part in additional training courses in-house or elsewhere. Your main working place will be in our offices in Leuven, Belgium (incl. flexible home-officing) but we also accept applications for remote working from European countries. Next to this you can count on a comprehensive and market conform remuneration package including extra-legal benefits. We offer a full-time permanent position.
Want to apply for this job?
Qaelum looks for quality and personality, if you have an interesting skillset, do not hesitate to send us your resume. We hire people based on skills and merit no matter your age, location in the world or background. If you have interest in this vacancy, please send your CV and motivation letter to