Senior QARA Medical Device at Excelya

Lyon, Auvergne-Rhône-Alpes, France -

Full Time

Start Date

Immediate

Expiry Date

06 Sep, 26

Salary

0.0

Posted On

08 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management System, ISO 13485, Regulatory Compliance, Design Control, Risk Management, Technical Documentation, Internal and External Audits, FDA Requirements, Stakeholder Management, Cross-functional Collaboration, English, French

Industry

Pharmaceutical Manufacturing

Description

At Excelya, we are committed to fostering an environment defined by Audacity, Care, and Energy. As a Clinical Operations Lead , you will play a vital role in enhancing our clinical research strategies and ensuring operational excellence across our studies. This position offers a unique opportunity for a regulatory affairs Manager to lead strategic regulatory initiatives while collaborating with cross-functional stakeholders to ensure the highest standards of quality and compliance. You will play a key role in driving regulatory excellence, supporting complex global submissions, and contributing to innovative development and lifecycle management strategies that shape the future of healthcare products. Main responsibilities : Maintain and continuously improve the Quality Management System (ISO 13485 compliant) Ensure regulatory compliance throughout product design and development in close collaboration with project teams. Oversee Design Control, risk management, and technical documentation activities. Define and implement the Quality and Regulatory Affairs strategy. Plan and manage internal and external audits. Develop, review, and optimize quality processes, procedures, and documentation. Manage product technical files and act as key contact for regulatory authorities and external stakeholders. Monitor regulatory changes (EU & US) and support internal capabilities, including FDA requirements. About you Education: Master’s degree in life sciences, pharmacy, chemistry, or a related field Experience: Proven experience in Regulatory Affairs within the pharmaceutical, biotech, or medical device industry, including involvement in global submissions and lifecycle management activities, experience in cross-functional collaboration or project coordination is a plus. At least 10 years of experience in QARA (Quality Assurance & Regulatory Affairs) within the medical device field. Significant experience with Class II medical devices. Skills: Strong knowledge of regulatory requirements and submission processes, as well as post-approval activities, good understanding of quality systems and product development; excellent communication, stakeholder management, and organizational skills. Languages: Fluent in English and French (written and spoken) Why Join Us? At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare. Here's what makes us unique— We are a young, ambitious health company representing 900 Excelyates, driven to become Europe's leading mid-size CRO with the best employee experience. Our one-stop provider service model — offering full-service, functional service provider, and consulting — enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey. Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity,and nurtures your potential, allowing you to contribute fully to our shared mission.

Responsibilities

Maintain and improve the ISO 13485 compliant Quality Management System while ensuring regulatory compliance throughout product design and development. Lead strategic regulatory initiatives, manage technical files, and oversee audits and risk management activities.