Senior Regulatory Affairs Specialist - H/F

🫀Who are we?
The creation of Volta Medical follows the discovery of a new medical approach to aid in the treatment of atrial fibrillation (the most common cardiac arrhythmia in the world) by the company’s founders, world experts in interventional electrophysiology and intracardiac signal analysis.  Volta Medical is an innovative start-up based in Marseille, whose goal is to provide a range of artificial intelligence-based products to guide the cardiologist during ablation-type procedures.  We started this adventure 7 years ago and our team now has nearly 120 employees in France, Germany and the United States! We completed a $27 million Series A round in November 2020 and a $38 million Series B round in January 2023. 

🫀Our Values

• Be a pioneer: Be brave. Don’t be scared of researching, exploring, trying and sometimes failing.
• Improve patients’ lives: Create products to provide electrophysiologists with the best userexperience possible, to help them improve the lives of patients.
• Strive for excellence: Push yourselves to deliver the highest quality in everything you do. Learn from your mistakes and aim for the best.
• Collaborate as a team: Welcome to a multidisciplinary and diversified team! Try to understand people from different cultures and environments. Confront your ideas and have fun!

🫀Missions

• Product Development: 
• Participates in the marketing strategy for new products
• Coordinates the creation and updating of devices Technical Documentation in compliance with applicable regulatory requirements and in close collaboration with various departments (R&D, production, clinical, quality)
• Participates in the writing of 510(k) and other premarket submissions 
• Assess the regulatory impacts of design changes
• Supports the registration of products and economic operators (new applications, modifications, renewals, maintenance) in Europe and the US
• Supports regulatory watch and gap analysis with respect to applicable regulatory requirements
• Manages product IFUs and verifies that product labeling, accompanying documents and promotional material comply with regulatory requirements
• Supports the creation and maintenance of products’ Risk Management File and Usability engineering File
• Regulatory Affairs process pilot deputy:  
• Handles the development and implementation of regulatory SOPs, instructions and forms
• Contributes to Post-Market Surveillance activities (PMS plan, PMS Reports, Periodic Safety Update Reports)
• Follow-up with associated KPIs and actions
• Audit and Inspection Preparation: 
• Prepares for audits and inspections
• Serves as the spokesperson for regulatory-related matters during audits and inspections
• Performs and follows up on internal and external audits to ensure regulatory compliance
• Collaboration and Support: 
• Acts as a leader for Regulatory Affairs activities  
• Collaborates with other teams as needed 
• Provides advice and support for other teams 
• Plays a key role in multi-functional teams to achieve cross-departmental objectives

🫀Profile

• Master’s degree in Science, Engineering, or related field
• Minimum of 5 years of experience in Regulatory Affairs 
• A first mentoring experience(including internship/apprenticeship) is a plus 
• Strong understanding of regulatory requirements, especially ISO 14971, IEC 62304, IEC 62366, IEC 81001-5-2, IEC 60601-1-2, AI act
• Experience with cross functionalteamwork especially as part of product development for a Medical Device incorporating software and AI
• Excellent communication skills, with the ability to work effectively with diverse teams  
• Analytical skills 
• Fluency in English and French

🫀What We Can Offer You At Volta Medical

• A pleasant work environment, with ideally located offices in the 6th district of Marseille offering a magnificent view upon Notre Dame de la Garde and the Mediterranean Sea.
• The possibility of working from home 2 days a week
• Passionate colleagues that have the same goal in mind: improve patients’ lives
• A corporate culture based on innovation, empowerment and collaboration.
• An international environment that allows you to practice your best american accent
• Regular team building events, breakfasts for gourmands and for the people enjoying sport activities
• And more traditional advantages: a lunch voucher card (Swile), a good health insurance (Benefiz), as well as exceptional days of absence on top of those provided in the collective agreement (compensation hold in case of illness starting from 6 months of seniority, additional days for a sick child, moving leave, etc.)

Join a company on a human scale, whose operations leave room for initiative and innovation in the service of patients.

🫀Recruitment Process

• Phone interview with our the HR team (30 min)
• Interview with our QARA Director and Chief Clinical and Regulatory Officer (60 min)
• Case study
• Culture fit interview with our Global VP of People and a Volta ambassador (60 min) 

Les informations que vous nous transmettez font l’objet d’un traitement de données à caractère personnel effectué par Volta Medical en qualité de responsable de traitement aux fins de gestion de votre candidature à un emploi. Vos informations sont destinées au service en charge du recrutement au sein de Volta Medical ainsi qu’aux personnes/organisations impliquées dans le recrutement du poste concerné. Vos informations sont conservées pendant la durée de l’examen de votre candidature. Si vous ne deviez pas être recruté, nous ne conserverions pas vos données. Cependant, si au moment du dépôt de votre candidature vous avez consenti à figurer dans notre base candidats, vos  données seront conservées pendant 2 ans à compter du dépôt initial de votre candidature afin de pouvoir vous proposer de nouvelles opportunité(s). Vous disposez cependant du droit de retirer votre consentement à tout moment. Volta Medical peut être amenée à effectuer des transferts de données vers un pays tiers à l'Union Européenne dans le cadre de ses activités, avec l'adoption de garanties appropriées. Vous trouverez ici notre « politique de confidentialité » qui explique de manière plus détaillée quels usages sont faits de vos informations, la manière dont elles sont exploitées et conservées ainsi que les bases légales sur lesquels reposent les traitements effectués. Y figurent également le rappel de vos droits concernant vos données personnelles et les moyens de nous contacter pour toute question ou demande.