Responsable Affaires réglementaires / Dispositif Médical
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What you'll do
- 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.
What they're looking for
- Master’s degree in life sciences, pharmacy, chemistry, or a related field
- Proven experience in Regulatory Affairs within the pharmaceutical, biotech, or medical device industry, including involvement in global submissions and lifecycle management activities
- At least 10 years of experience in QARA (Quality Assurance & Regulatory Affairs) within the medical device field
- Significant experience with Class II medical devices
- 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
- Fluent in English and French (written and spoken)
Nice to have
- Experience in cross-functional collaboration or project coordination is a plus
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
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 :
- Develop and implement regulatory strategies to support product development, registration, and market access activities
- Prepare, maintain, and update Technical Documentation in accordance with MDR 2017/745 requirements.
- Coordinate CE Marking activities
- Assess the regulatory impact of product changes throughout the product lifecycle.
- Ensure compliance with applicable standards and regulations, including MDR 2017/745, ISO 13485, and ISO 14971.
- Support Post-Market Surveillance (PMS), Vigilance, and Post-Market Clinical Follow-up (PMCF) activities.
- Participate in internal and external audits, inspections, and regulatory assessments.
- Interface with Competent Authorities, and external regulatory partners.
- Monitor and interpret regulatory developments and communicate potential impacts to stakeholders.
- Collaborate closely with Quality Assurance, R&D, Clinical, Manufacturing, and Marketing teams to ensure regulatory compliance.
- Provide regulatory guidance and training to cross-functional teams.
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)
Benefits
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.
Company
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