Regulatory Affairs Officer

INDIBA Group; Sant Quirze del Vallès; Hybrid; EUR 48,000 - 66,000; Full time

Benefits offered by this job

Hybrid working model

Fringe benefits

International atmosphere

Job summary

INDIBA Group in Sant Quirze del Vallès is looking for a Regulatory Affairs Specialist to obtain, update and maintain worldwide regulatory approvals for medical devices and cosmetics. You will work across regions to ensure compliance with regulatory requirements and maintain the quality systems in place.

The role requires a degree in a health sciences field and at least three years of regulatory affairs experience, with strong knowledge of MDR 2017/745, ISO 13485 and experience with US FDA

Qualifications

• Experience in regulatory submissions and health authorities lead times.
• Knowledge of MDR 2017/745 and ISO 13485.
• Familiarity with US FDA regulations and MDSAP countries is a plus.

Responsibilities

• Process regulatory submissions to obtain market clearances.
• Support CE marking activities and technical file preparation.
• Ensure regulatory compliance across EU, US, Japan, Australia and Korea.

Skills

Regulatory affairs

Medical devices

Quality systems

Cross-functional coordination

Education

Degree in health sciences / bioengineering / chemistry / biology / pharmacy

Job description

About Us

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.
Revitalizing lives is what we do—and what our teams around the world strive to achieve every day.

What are we looking for?

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.

What will your responsibilities be?

• 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 standard 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.

What do you need to be a successful candidate?

• 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.

What do we offer?

• A full-time, permanent contract.
• Location: Sant Quirze del Vallès.
• A hybrid working model.
• An attractive remuneration package.
• Fringe benefits.
• A flexible, international working environment.