Responsable Affaires réglementaires / Dispositif Médical

Excelya; Dijon; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Excelya is seeking a Regulatory Affairs Manager to lead strategic regulatory initiatives and drive regulatory excellence across global submissions and lifecycle management. The role collaborates with QA, R&D, Clinical, Manufacturing, and Marketing to ensure compliance and timely market access.

The ideal candidate has deep expertise in MDR/IVDR, ISO standards, and a track record of cross-functional collaboration in medical devices or pharma settings.

Qualifications

• Education: Master's degree in life sciences, pharmacy, chemistry, or a related field.
• Experience: Proven Regulatory Affairs experience in pharma/biotech/medical device with global submissions and lifecycle management.
• Significant experience with Class II medical devices and QARA responsibilities.

Responsabilités

• Develop and implement regulatory strategies to support product development, registration, and market access activities.
• Prepare, maintain, and update Technical Documentation per MDR 2017/745 requirements.
• Coordinate CE Marking activities.
• Assess regulatory impact of product changes across the lifecycle.
• Ensure compliance with MDR 2017/745, ISO 13485, ISO 14971.
• Support PMS, Vigilance, PMCF activities.
• Participate in audits, inspections, and regulatory assessments.
• Interface with Competent Authorities and external regulatory partners.
• Monitor regulatory developments and communicate impacts to stakeholders.
• Collaborate with QA, R&D, Clinical, Manufacturing, and Marketing for compliance.
• Provide regulatory guidance and training to cross-functional teams.

Connaissances

Regulatory strategy

Global submissions

Cross-functional collaboration

Stakeholder management

Quality systems

Regulatory requirements

Formation

Master's degree in life sciences/related field

Description du poste

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

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

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

WhyJoinUs?

AtExcelya,wecombinepassionforsciencewithenthusiasmforteamworktoredefineexcellenceinhealthcare.

Here’swhatmakesusunique

Weareayoung,ambitioushealthcompanyrepresenting900Excelyates,driventobecomeEurope'sleadingmid-sizeCROwiththebestemployeeexperience.Ourone-stopproviderservicemodelofferingfull-service,functionalserviceprovider,andconsultingenablesyoutoevolvethroughdiverseprojects.Workingalongsidepreeminentexperts,youwillhelpimprovescientific,operational,andhumanknowledgetoenhancethepatient'sjourney.

Excellingwithcaremeansbenefitingfromanenvironmentthatvaluesyournaturaltalents,pushesboundarieswithaudacity,andnurturesyourpotential,allowingyoutocontributefullytooursharedmission.