Xaga Surgical is a Swedish medtech startup reinventing the medical needle to improve patient safety and cancer diagnostics. For more information, visit www.xagasurgical.com.

At Xaga Surgical you will get the opportunity to be part of a fantastic journey where you will play a crucial role in launching products world-wide and scaling up the company.

In this position you will have the main responsibility for all QA/RA activities. Xaga Surgical has recently obtained a 510 (k) clearance for the US market and together with expansion plans for EU, and rest of the world, you will contribute with critical competence in regulatory compliance.

Xaga Surgical is a growing medical device company with considerable market potential, where you will have the opportunity to shape how quality and regulatory compliance are integrated into every aspect of the business – from product development to market success. This is a key position to support development and commercialization of new products.

Your main responsibility covers QA/RA, but working in a smaller company means you will be heavily involved in for example R&D and production-related matters as well.

Your responsibility:

• All QA/RA-related questions.
• Maintain and develop the Quality Management System.
• Ensure compliance with MDR, FDA QSR, ISO 13485, and other regulatory requirements.
• Provide QA support in design, development, production, and product release.
• Regulatory compliance in the role as PRRC (Person Responsible for Regulatory Compliance).
• Participate in the preparation and execution of internal and external audits and inspections.
• Develop and improve processes and ways of working.

You will be reporting to COO, and the position is based in Lund, or home based in Skåne.

Candidate profile
We are looking for a candidate with solid professional Regulatory Affairs and Quality Assurance experience, working on medical device products. This means, you have profound knowledge within medical device regulatory activities, including MDR and ISO 13485, and proficiency in relevant regulatory-related regulations and guidelines. Probably, you have a Bachelor or Master of Science degree. With the above-mentioned profile, you will meet the requirements for the role as PRRC.

It is considered a very strong merit if you have experience from working in a start-up company, together with experience from US (FDA) market aproaval, and knowledge about production in Asia.

Excellent communication and documentation skills (oral/written) in English are required.

To be successful in this role, you need a structured and organised mindset together with strong focus on details and time management. Even though you are highly structured, you support change and can adapt to new conditions – which is often the case in a small and growing company. We value a pragmatic and hands-on “roll up the sleeves” attitude. You are self-going and have the ability to work independently which means you can easily prioritise and make decisions – without running a one-man show.

Xaga Surgical offers
This is a great opportunity to join a highly dynamic company in its early phase. We offer you an interesting journey being part of supporting new market applications and scaling up the business – and it’s supportive processes. Xaga Surgical’s main goal is to create medical needles that prioritise patient safety and ease for healthcare professionals while offering cost-effectiveness for users and society as a whole. You will contribute to saving human lives! There is a considerable market potential for safe and modern medical needles. The product is proven and waits to be made available in a number of markets. Xaga Surgical is well funded and you will be offered the possibility to buy stock options. A lot of work remains, but the reward can be high. Last but not least, you have a funny time along the journey, with a lot of freedom.

Information and application
For more information about this job-opening, please contact recruitment consultant Tobias Lorentzon at TOBLOR Consulting, phone: +46 735 11 10 60. You apply for this position through TOBLOR’s career site, https://career.toblor.se/, by uploading your CV and personal letter.

We are looking forward to seeing your application!