The RAQA Specialist will join the RAQA team working with the Head of RAQA to help: secure our compliance with Regulatory and Quality requirements for Sonio’s products in all relevant geographies.

Key missions :

• Develop and execute regulatory submission strategies for assigned projects

• Prepare and submit regulatory submission files (CE mark, FDA …)

• Ensure regulatory activities related to product development and/or product modification

• Support the development of international regulatory strategies

• Participate in Post-Market Surveillance activities

• Support quality management system continuous improvement in accordance with the applicable regulations and standards (ISO 13485, FDA 21 CFR…);

• Train and support the entire team in maintaining good practices and procedures;

• Participate in regulatory agency inspections and audits.

Sonio is a mission-driven company so interest in our mission is critical. Other requirements are:

• Engineering Degree or MsC in Regulatory Affairs or Medical/Scientific field

• 1-3 years of experience in a quality and regulatory affairs position for medical devices

• Familiar with EU regulation (MDR 2017/745) and QMS regulation (ISO 13485, 21 CFR)

• Great capacity for relational adaptation to integrate a young dynamic team

• Great technical skills and operational excellence

• Proactivity and will to achieve ambitious goals

• Transparency, humility and respect

• Good level of English (written/oral)