INDIBA Group is a global medical device company specializing in radiofrequency and laser technologies for the physiotherapy, aesthetics and veterinary markets. With more than 40 years of scientific research and innovation, our technologies and solutions are used by healthcare professionals worldwide.
Through our INDIBA and K-LASER brands , we combine science, technology and clinical expertise to develop solutions that enhance health, well-being and quality of life for people and animals alike.
We are looking for a Regulatory Affairs Specialist to join our office in Sant Quirze del Vallès.
In this role, you will be responsible for obtaining, updating and maintaining regulatory approvals worldwide for the sale of medical devices for both medical and non-medical purposes.
Although medical devices make up the core of our portfolio, the Regulatory team is also responsible for cosmetic products.
Ensure regulatory compliance in the regions where our medical devices are marketed,
including—but not limited to—the European Union, the United States, Japan, Australia and South Korea.
Support the preparation and submission of medical device technical files and cosmetic product dossiers, ensuring that all regulatory deliverables meet the required quality standards and deadlines.
Support the maintenance and development of our existing Quality Management Systems, including ISO 13485 and MDSAP.
At least three years of experience in regulatory affairs within a medical device or pharmaceutical company, or a regulatory consultancy.
In-depth knowledge of medical device legislation, particularly the Medical Device Regulation (MDR) 2017/745 and ISO 13485. Fluency in Spanish and English, both written and spoken. A full-time, permanent contract.
A hybrid working model.
A adaptable, international working environment.