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)
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