Regulatory Affairs & QMS Officer

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About Us

INDIBA is a global medical device company specializing in Radiofrequency (RF) and Laser solutions for physiotherapy, aesthetic, and veterinary markets. We are renowned worldwide for our scientific research over the past 40 years.

At INDIBA, we believe in contributing to health and well-being by addressing new and growing needs, enabling people to maintain their lifestyles at older ages, and caring for animals too.

Revitalizing lives is our mission, and our teams work daily towards this goal.

What are we looking for?

We are seeking a Regulatory & QMS Officer for our office in Sant Quirze del Vallès. The candidate will be responsible for obtaining, updating, and maintaining regulatory approvals for medical devices (both medical and non-medical purposes).

The core portfolio includes medical devices, and the Regulatory team also handles cosmetic products. The role involves maintaining the Quality Management System in compliance with ISO 13485 and MDSAP standards, collaborating with departments such as Quality Assurance, R&D, and Medical.

Responsibilities

Regulatory Affairs

• Participate in regulatory processes to obtain market clearances through health authorities.
• Assist with new claim submissions and CE Marking.
• Support regulatory compliance in regions like the EU, USA, Japan, Australia, and South Korea.
• Assist in creating and submitting technical files and cosmetic dossiers, ensuring quality and timeliness.
• Coordinate workflows with internal and external stakeholders.
• Stay updated on relevant legislation.

Quality Management System

Candidate Requirements

What We Offer

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