FDA Regulatory Affairs Director

ResponsibilitiesConduct regulatory impact assessments for product changes, including determination of letter-to-file versus submission requirements.Manage annual registrations, license renewals, and ongoing regulatory notifications.Support the preparation, submission, and maintenance of FDA dossiers and related technical documentation.Coordinate the...

What We Will Accomplish TogetherAlsinova, asubsidiary of the Astek Group, is a consulting firm specialized inLife Sciences. We support pharmaceutical, biotech, and medtech companies by providing high-level expertise inregulatory affairs, clinical development, data, quality, and pharmacovigilance. To support one of our major partners in thein vitro...

des Affaires Réglementaires - Produits combinésNotre client, reconnu pour son expertise en technologies d'injection et d'administration de médicaments, recrute un.e Associé.e des Affaires Réglementaires. Basé en région Rhône-Alpes Grenoble, ce rôle clé vous permettra de piloter les initiatives réglementaires, garantir la conformité des produits...

We are seeking an Dermatologist - Medical Director to join our dynamic team. The Medical Director will have overall responsibility for providing medical, scientific, and strategic leadership for the successful planning, execution, and reporting of clinical trials. Additionally, this role acts as the Medpace internal medical expert and will serve as a medical...

We are seeking a Psichiatry Medical Director to join our dynamic team. The Medical Director will have overall responsibility for providing medical, scientific, and strategic leadership for the successful planning, execution, and reporting of clinical trials. Additionally, this role acts as the Medpace internal medical expert and will serve as a medical...

We are seeking a Pediatric / Neuromuscular neurologist - Medical Director to join our dynamic team. The Medical Director will have overall responsibility for providing medical, scientific, and strategic leadership for the successful planning, execution, and reporting of clinical trials. Additionally, this role acts as the Medpace internal medical expert and...

Contract Opportunity: Manufacturing Engineer - Medical Devices (ISO 13485)Location: Lyon, FranceContract Duration: 12 monthsStart Date: ImmediateEngagement Type: FreelanceA leading medical device manufacturer is seeking an experienced Manufacturing Engineer to support advanced production operations in compliance with ISO 13485 and EU MDR standards. This is a...

Company Description With sales of €600m and 3,000 employees worldwide, Nemera is one of the leading global manufacturers of complex drug delivery systems for the pharmaceutical industry, offering to patients a broad product portfolio which includes inhalation devices, injection devices, nasal and dermal pumps and ophthalmic delivery devices. Nemera has...

Le posteResponsable Affaires Réglementaires & Qualité Senior (MedTech / IA / Santé)Vous êtes un·e expert·e des affaires réglementaires avec une solide expérience en dispositifs médicaux de classe IIb (MDR) ? Vous cherchez un projet à fort impact sociétal et scientifique ? Rejoignez PREVIA, une MedTech innovante qui révolutionne la détection...

Company DescriptionAbout M3: A Japanese global leader in the provision of ground-breaking and innovative technological and research solutions to the healthcare industry. The M3 Group operates in the US, Asia, and Europe with over 5.8 million physician members globally via its physician websites which include , , , , , and M3 Inc. is a publicly traded...