Regulatory Affairs Officer
il y a 23 heures
Regulatory Affairs Officer - Lyon, France (F/M)Join to apply for the Regulatory Affairs Officer - Lyon, France (F/M) role at Astek.About UsAlsinova, a subsidiary of the Astek Group, specializes in Life Sciences. We support pharmaceutical, biotech, and medtech companies with expertise in regulatory affairs, clinical development, data, quality, and pharmacovigilance. Currently, we are seeking a Regulatory Affairs Officer experienced in IVDR compliance and medical devices to support our partner in the in vitro diagnostics (IVD) sector.Your MissionAs a Regulatory Affairs Officer, you will ensure our IVD products comply with evolving IVDR regulations and standards.Daily ResponsibilitiesSupport CE marking activities under IVDRPrepare, review, and update technical documentation (TD) for IVD products per IVDR Annex II & IIIEnsure labeling, Instructions for Use (IFU), and claims meet IVDR and national regulationsParticipate in gap assessments, risk management, and post-market surveillanceEngage with notified bodies or regulatory authorities as neededCollaborate with QA, R&D, Clinical, and Marketing teamsCandidate ProfileHigher education in Life Sciences, Regulatory Affairs, or related fields2–5 years of regulatory affairs experience in medical devices or IVDsStrong understanding of EU Regulation 2017/746 (IVDR)Experience with technical documentation, CE marking, and notified body submissionsKnowledge of ISO 13485, ISO 14971, and post-market requirementsProactive, detail-oriented, independent worker in a dynamic environmentExcellent English communication skills; French is a plusWhy Join UsAt Astek, you gain:Opportunities for professional growthEngagement in exciting projectsPersonalized career supportContinuous learning through our internal AcademyAn inclusive, friendly work environmentOur ValuesRespect for employees and clientsPersonalized supportRegular career developmentTransparent communicationResponsiveness and attentivenessAdditional DetailsSeniority level: Mid-SeniorEmployment type: Full-timeJob function: LegalIndustries: IT Services and ConsultingReferrals can double your chances of interview success. Sign in to set job alerts for similar roles. #J-18808-Ljbffr
-
Regulatory Affairs Officer
il y a 2 semaines
Lyon, Auvergne-Rhône-Alpes, France Excelya Temps pleinAbout the JobExcelya is seeking a talented Regulatory Affairs Officer specializing in Advertising and Promotional Materials. At Excelya, we prioritize Audacity, Care, and Energy in our professional endeavors, supporting our mission to deliver high-quality healthcare solutions.As a Regulatory Affairs Officer, you will play a key role in reviewing and...
-
Regulatory Affairs Officer
il y a 2 semaines
Lyon, Auvergne-Rhône-Alpes, France EXCELYA Temps pleinAbout the JobExcelya is seeking a talented Regulatory Affairs Officer specializing in Advertising and Promotional Materials. At Excelya, we prioritize Audacity, Care, and Energy in our professional endeavors, supporting our mission to deliver high-quality healthcare solutions.As a Regulatory Affairs Officer, you will play a key role in reviewing and...
-
Regulatory Affairs Officer F
il y a 1 jour
Lyon, France Astek Temps pleinAlsinova, the Astek Group subsidiary offering a complete CRO solution, is recruiting a Senior Preclinical Biostatistician for a project in the pharmaceutical sector. Your mission (should you decide to accept it) As a Regulatory Affairs Officer, you will contribute to ensuring that the company's IVD products remain compliant with the evolving IVDR regulations...
-
FDA Regulatory Affairs Director
il y a 7 jours
Lyon, Auvergne-Rhône-Alpes, France Resourcing Group Temps pleinRole DescriptionLine management, training of colleaguesEstablish and implement regulatory strategies ensuring new and existing products comply with the latest global requirements.Training the team with EMEA / FDA requirementsQualificationsMin 8 years in regulatory affairs in medical deviceMin 4 years as Regulatory Affairs ManagerExperience with EMEA / FDA...
-
Regulatory Affairs Associate
il y a 5 jours
Lyon, Auvergne-Rhône-Alpes, France Resourcing Life-Science Temps pleinResponsibilitiesConduct 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...
-
Regulatory Affairs
il y a 1 jour
Lyon, France Alan Temps pleinRegulatory Affairs & Governance Lead – Alan Alan is a vertically integrated health partner that seamlessly unites insurance and smart healthcare delivery into one system. Our mission is to help people live in good health while turning employer health benefits into a valuable investment. About the Role The Risk team drives Alan’s resilience by guiding...
-
Regulatory Affairs Specialist
il y a 1 jour
Lyon, France ResMed Inc Temps pleinRegulatory Affairs Specialist page is loaded## Regulatory Affairs Specialistlocations: Saint-Priest, Lyon, Francetime type: Full timeposted on: Posted Todayjob requisition id: JR\_046400**Contexte et objectifs du poste**Au sein de l’équipe Regulatory Affairs EMEA, vous jouerez un rôle clé dans la gestion de toutes les activités réglementaires...
-
Regulatory Affairs Specialist F/m 1
il y a 2 semaines
Lyon, France bioMérieux sa Temps pleinA family-owned company, bioMérieux has grown to become **a world leader in the field of in vitro diagnostics**. For almost 60 years and across the world, we have imagined and developed **innovative diagnostics solutions** to **improve public health**. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large...
-
Chemical Regulatory Affairs Manager – LyonNonStop Consulting
il y a 1 semaine
Lyon, France NonStop Consulting Temps pleinChemical Regulatory Manager – Lyon Our client, a leading global provider of market expansion services with a strong presence in the chemical industry, is seeking a skilled and dedicated Chemical Regulatory Manager. This pivotal role will be based at their offices on the periphery of Lyon, with a flexible hybrid model allowing for 2 days of home working per...
-
Regulatory Affairs
il y a 2 heures
Lyon, Auvergne-Rhône-Alpes, France Alan Temps pleinWho we areYou. Better. With Alan.Alan's vision is to make prevention the new norm of care for all.Our mission is to help people live in good health to 100 while helping employers feel proud, turning health benefits from a cost centre into their most valuable investment.We're building avertically integrated health partnerthat seamlessly unites insurance and...
