Affaires Reglementaires jobs in France

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Beyond Conception GmbH

toulon, France

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69177547883020288327650

1

15.05.2025

29.06.2025

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As an RA (Senior) Consultant , you will play a pivotal role in supporting pharmaceutical and medical device clients in the development, submission, and lifecycle management of drug-delivery devices and combination products. You will lead and guide a variety of regulatory projects, providing expert advice on regulatory strategies, classifications, and pathways, while collaborating closely with R&D teams to develop new products or manage the lifecycle of authorized ones. You will be responsible for the end-to-end regulatory support and will contribute significantly to the successful market entry and maintenance of combination products in key regulatory regions, including the EU and US.Key responsibilities include:Leading and implementing the regulatory strategy development for drug-delivery devices and combination products.Providing guidance on regulatory classification and submission pathways for the EU (MDR, CE Marking) and the US (FDA, 510(k), PMA, NDA, BLA, ANDA).Supporting R&D teams in the development phase, from design control to quality management, ensuring compliance with applicable technical standards and regulatory frameworks.Liaising with key internal stakeholders, including RA CMC, Manufacturing, Clinical Development, and Marketing, to compile dossiers and technical documentation for regulatory submissions.Drafting/reviewing relevant device sections of eCTD modules (e.g. 3.2.R, 3.2.P.2) for combination products applicationsManaging communications with notified bodies and health authorities, including participation in audits and inspections.Mentoring other consultants and sharing knowledge within the team, contributing to internal training and developmentYour Profile:You are an independent and proactive professional with a passion for contributing to cutting-edge regulatory projects. You thrive in dynamic environments and are adept at adjusting to clients' needs while ensuring high-quality regulatory outcomes. You are eager to continually learn and share knowledge with both clients and internal teams, demonstrating a strong commitment to your professional development.You possess:Min 8–12 years of relevant experience in Regulatory Affairs and/or R&D related to:Drug-delivery devices (e.g., pre-filled syringes, autoinjectors, dry powder/metered dose inhalers, oral/nasal vaccines, blow-fill seals).Combination products under EU (MDR, CE Marking, Notified Body Opinion) and/or US (FDA, 510(k), PMA, NDA, BLA, ANDA) regulatory frameworks.Quality Management Systems for medical devices and combination products (ISO 13485, MDR, 21 CFR 820/QSR/QMSR, ISO 14971).Solid expertise in the development of devices under design controls and familiarity with technical standards applicable to drug-delivery devices.Experience in supporting R&D teams through the development phases of combination products.Ability to independently manage projects and stakeholder relationships, leading regulatory strategies for multiple clients in parallel.Experience working cross-functionally with RA CMC, Manufacturing, Clinical, and Commercial teams to compile technical documentation and regulatory submissions.Proven experience in handling NB/FDA/NCA audits and inspections.University degree in Biomedical Engineering, Pharmacy, Health Technology, Medical Science, or another relevant field.Fluency in English (required) and French (desired).