Regulatory Affairs Officer Medical Device H/F Excelya
- Paris - 75
- CDI
- Bac +5
- Industrie Pharmaceutique • Biotechn. • Chimie
Les missions du poste
About the Job
Join Excelya as a Regulatory Affairs Officer specializing in Medical Devices, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.
This role is an exciting opportunity to contribute to a dynamic, ambitious team in Regulatory Affairs. You will play a critical part in driving innovation and making an impact in the medical device sector, while enjoying a stimulating professional environment that encourages personal and intellectual growth.
Main Responsibilities:
- Manage regulatory submissions for medical devices in accordance with U.S. FDA and EU MDR/IVDR requirements.
- Review and assess technical documentation for compliance with regulations, including risk assessments and clinical evaluations.
- Prepare and maintain regulatory files and submissions, ensuring accuracy and completeness.
- Collaborate with cross-functional teams to ensure timely product launches and compliance with post-market surveillance activities.
- Stay updated on regulatory changes and advise the organization on potential impacts on products and processes.
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'sleading mid-size CROwith thebest employee experience. Ourone-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 caremeans 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.
About You:
We are looking for a dedicated and knowledgeable professional with strong expertise in regulatory affairs for medical devices.
- Experience: Minimum of 3-5 years in regulatory affairs, specifically related to medical devices. Proven experience with regulatory submissions
- Skills: In-depth understanding of EU and U.S. medical device regulations, excellent analytical and communication skills, and strong attention to detail.
- Education: Degree in Pharmacy, Biomedical Engineering, Life Sciences, or a related field.
- Languages: Fluency in English and French is required; additional languages are a plus.
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.
Hellowork a estimé le salaire pour cette offre
Cette estimation de salaire pour le poste de Regulatory Affairs Officer Medical Device H/F à Paris est calculée grâce à des offres similaires et aux données de l’INSEE.
Cette fourchette est variable selon expérience.
Salaire brut min
42 200 € / an 3 517 € / mois 23,19 € / heureSalaire brut estimé
50 000 € / an 4 167 € / mois 27,47 € / heureSalaire brut max
62 500 € / an 5 208 € / mois 34,34 € / heureCette information vous semble-t-elle utile ?
Merci pour votre retour !
Publiée le 23/09/2025 - Réf : 035ee995-548d-4bf7-8a28-699f67fe31b2
Regulatory Affairs Officer Medical Device H/F
- Paris - 75
- CDI
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