Regulatory Affairs
il y a 23 heures
Regulatory 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 operational teams to evaluate risks, analyze business impacts, and design agile mitigation strategies. As the Regulatory Affairs & Governance Lead, you will be a strategic lever for the Risk and Product teams, acting as the bridge between business operations and regulatory stakeholders across multiple jurisdictions. Key Responsibilities Regulatory Relations: Lead and coordinate relationships with regulators in our markets (ACPR in France, FSMA in Belgium, OSFI in Canada, and future authorities); manage strategic regulatory communications and sequencing; prepare and coordinate annual regulatory meetings, ACPR touchpoints, and ad‑hoc requests; open regulatory doors to secure Alan’s future plans. Strategic Projects Support: Provide regulatory guidance on strategic projects such as new market entries, product launches, and corporate restructuring; assess regulatory implications for new initiatives; own and coordinate strategic regulatory elements in our roadmap, ensuring timely and compliant launch. Governance Framework: Own and maintain written policies; support risk governance processes; contribute to regulatory and committee reporting across geographies; monitor regulatory changes and assess impact on operations. Cross‑Functional Collaboration: Work closely with country general managers, product leaders, Risk, Insurance, Legal, Corporate leadership, and Finance; coordinate and anticipate regulatory initiatives; translate complex regulatory requirements into actionable guidance for operational teams. Desired Experience & Skills 5+ years of experience in insurance risk/compliance/regulatory roles or consulting firms supporting risk teams, or prior regulator experience (ex‑ACPR, DG Trésor, AMF). Knowledge of Solvency II governance pillar (Pillar 2) and insurance law. Excellent stakeholder management and handling of regulators and senior executives. Strong project management capabilities for complex regulatory projects. Fluent in English and French with strong written communication skills. Ability to thrive in ambiguity, cross‑functional work, and to translate technical topics for external audiences. Ego‑free, focused on enabling others rather than managing large teams. Self‑starter mindset, independent work in a fast‑paced, high‑growth environment. Bonus Points International insurance experience across multiple jurisdictions. Experience supporting high‑growth companies through regulatory scaling. Perks & Benefits Fair rewards – generous equity packages complement base salary. Flexible office and remote options with home‑office equipment sponsorship. All‑the‑tools‑you‑need – MacBook Pro, keyboard, laptop stand, monitor, Bose headphones. Flexible vacation policy and working hours. Extremely comprehensive health insurance – 100% for you and children, 90‑100% for partners. Transport commuter benefits. Learning & training opportunities – free books and budget for conferences. Personal growth through coaching – dedicated coach from day one. Parental leave – extended for all new parents. EEO Statement We hire people, not roles. Everyone, underrepresented or otherwise, is encouraged to apply. If you identify as a woman, we recognize the importance of inclusive opportunities. #J-18808-Ljbffr
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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...
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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...
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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...
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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...
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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...
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Regulatory Affairs Officer
il y a 19 heures
Lyon, France Astek Temps pleinRegulatory 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...
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Regulatory Affairs Officer F
il y a 24 heures
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...
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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...
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Senior Regulatory Affairs Manager, Medical Devices
il y a 2 semaines
Lyon, France Nemera Temps pleinA leading medical device company in Lyon is looking for a passionate Regulatory Affairs Manager to lead regulatory and compliance projects across various business units. Key responsibilities include managing a team, developing regulatory strategies, and ensuring compliance with ISO standards. The ideal candidate has a Master’s degree and extensive...
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IVDR Regulatory Affairs Specialist – IVD Compliance
il y a 24 heures
Lyon, France Astek Temps pleinA leading CRO solutions provider is recruiting a Senior Preclinical Biostatistician in Lyon, France. The role focuses on ensuring compliance with evolving IVDR regulations. Candidates should have a higher education in Life Sciences and 2-5 years of experience in regulatory affairs for medical devices or IVDs. Key responsibilities include preparing technical...