We are looking for a hands-on and strategic Regulatory Affairs & Quality Assurance Manager to help bring our technology from development to global commercialization. You will work at the intersection of innovation, product development, clinical validation, and regulatory strategy, helping the company move fast while maintaining the highest standards of quality and patient safety.

Skills & Experience

• Medical or scientific background (Pharmacist, Engineer, Master’s degree in Quality/Regulatory Affairs for medical devices, or equivalent).

• At least 3 years of experience in Quality Assurance and Regulatory Affairs within the medical device industry.

• Experience with electromedical devices combining hardware and software is a strong plus.

• Strong knowledge of medical device regulations and standards, particularly ISO 13485, FDA regulations, IEC 62304, ISO 14971, and the IEC 60601 series.

• Prove...