Regulatory Affairs & QMS Officer

INDIBA, is a global medical device company in the field of Radiofrequency (RF) and Laser solutions for the physiotherapy, aesthetic and veterinary markets, and is known in the world for its scientific research performed in the last 40 years.

At INDIBA we believe we can contribute to the health and well-being of our patients by addressing new and growing needs offering treatments that will allow people to continue their lifestyle at an older age and animals too.

Revitalizing lives is what we do and what our teams are working on to achieve daily.

Overview What are we looking for?

We are actively seeking a Regulatory & QMS Officer for our office in Sant Quirze del Vallès.

The individual will be responsible for obtaining, updating and maintaining regulatory approvals for the sale of Medical Devices (medical and non-medical purpose).

The core of the portfolio is made of medical devices, nevertheless, the Regulatory team is also responsible for cosmetic products.

This role also includes maintaining the Quality Management System in compliance with ISO 13485 and MDSAP standards. Collaborating with several departments as Quality Assurance, R&D, Medical, etc.

Responsibilities Regulatory Affairs Participate in regulatory processes to obtain clearances for new markets through their Health Ministries or regulatory agents. The Regulatory team leads such processes.

Participate in new claim submissions and product CE Mark.

Provide support for assure the regulatory compliance in the regions in which medical devices are marketed, including, but not limited to; European Union, USA, Japan, Australia, South Korea, etc.

Provide support for medical device technical files and cosmetic dossiers creation and submission while ensuring quality and timeliness of regulatory deliverables.

Coordinate work-flow with colleagues (internal and external stakeholders) as necessary.

Keep up to date with relevant legislation.

Quality Management System Support on the maintenance and development of existing Quality Management Systems (ISO13485, MDSAP)

Work internally to ensure compliance with the quality standards and legal regulations in accordance with national and international requirements departments, best practices and legislation.

Support internal and external audit program to guarantee the normative compliance, the effectiveness of the system.

What do you need to be a succesful candidate? Degree in health sciences; chemistry, biology or pharmacy or similar.

Minimum of 2 years’ experience in regulatory affairs in a Pharmaceutical, Medical Devices company or regulatory consultancy.

In-depth understanding and knowledge of medical device legislation (93 / 42 / EEC incl. 2007 / 47 / EC, MDR 2017 / 745) and ISO13485 quality standards.

US FDA regulation knowledge will be a plus.

Fluent Spanish & English language skills in both verbal and written communication. Fluency in another language will be a plus.

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