Responsable Affaires Réglementaires - Dispositif Médical H/F - Excelya

Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.

Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.

We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.

Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.

At Excelya, we are committed to fostering an environment defined byAudacity, 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.

WhyJoinUs?

AtExcelya,wecombinepassionforsciencewithenthusiasmforteamworktoredefineexcellenceinhealthcare.

Here'swhatmakesusunique-

Weareayoung,ambitioushealthcompanyrepresenting900Excelyates,driventobecomeEurope'sleadingmid-sizeCROwiththebestemployeeexperience.Ourone-stopproviderservicemodel-offeringfull-service,functionalserviceprovider,andconsulting-enablesyoutoevolvethroughdiverseprojects.Workingalongsidepreeminentexperts,youwillhelpimprovescientific,operational,andhumanknowledgetoenhancethepatient'sjourney.

Excellingwithcaremeansbenefitingfromanenvironmentthatvaluesyournaturaltalents,pushesboundarieswithaudacity,andnurturesyourpotential,allowingyoutocontributefullytooursharedmission.

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)