Regulatory Affairs Officer

INDIBA K-LASER; Sant Quirze del Vallès; Presencial; EUR 42 000 - 62 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Hybrid working model

Fringe benefits

International working environment

Resumo da oferta

INDIBA Group is seeking a Regulatory Affairs Specialist to join our Sant Quirze del Vallès office. You will manage regulatory approvals worldwide for medical devices and cosmetics, ensuring compliance and timely submissions.

Qualifications include a degree in health sciences or related field, 3+ years in regulatory affairs, and strong knowledge of MDR 2017/745 and ISO 13485. Bilingual Spanish/English is required, with additional languages a plus.

Qualificações

• 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, MDR 2017/745 and ISO 13485; experience with Annex XVI devices is a plus.
• Knowledge of US FDA regulations and other MDSAP countries is a plus.
• Fluency in Spanish and English, additional language is a plus.

Responsabilidades

• Participate in regulatory processes to obtain market clearances through health ministries and regulatory authorities.
• Support new claim submissions and product CE marking activities.
• Ensure regulatory compliance in regions where devices are marketed (EU, US, Japan, Australia, South Korea).
• Support preparation and submission of medical device technical files and cosmetic product dossiers.

Conhecimentos

Regulatory affairs

Medical devices

Quality systems

Bilingual Spanish/English

Formação académica

Health sciences / related field degree

Descrição da oferta de emprego

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 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.

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.