Regulatory Affairs Officer

• A degree in health sciences, bioengineering, chemistry, biology, pharmacy or a related field.

• 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. Experience with devices covered by Annex XVI, relating to products without an intended medical purpose, will be an advantage.

• Knowledge of US FDA regulations and other MDSAP countries will be an advantage.

• Fluency in Spanish and English, both written and spoken. Fluency in an additional language will be an advantage.

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.

• Participate in regulatory processes to obtain market clearances through health ministries and regulatory authorities. The Regulatory team leads these processes.

• Support new claim submissions and product CE marking activities.

• 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.

• Coordinate workflows with colleagues and internal and external stakeholders as needed.

• Stay up to date with relevant legislation and regulatory requirements.

• Support the maintenance and development of our existing Quality Management Systems, including ISO 13485 and MDSAP.