Manager, Regulatory Affairs
Pubblicato il 06-09-2026 - Taevas Life Sciences in Italia
Leadership Tempo pieno OnsiteExperience Required7.0 Scorra verso il basso per trovare i dettagli completi dell'offerta, inclusa l'esperienza richiesta e le mansioni associate. - 10.0 YearsJob DescriptionThe Global Regulatory Affairs Lead is responsible for end-to-end product registrations and regulatory strategy across multiple geographies.This role ensures that all Taevas products meet country-specific regulatory requirements and are approved for market entry in a timely and compliant manner.Key ResponsibilitiesGlobal Product RegistrationsLead regulatory submissions across key markets (India, US, EU, UAE, LATAM, APAC, etc.).Manage technical documentation (Technical File, STED, DMF, CER,
etc.).Regulatory StrategyDefine registration pathways for new products and markets.Provide regulatory feasibility inputs during product selection / OEM onboarding.Stakeholder & Agency ManagementLiaise with Notified Bodies, regulatory consultants, labs, and local agents.Coordinate with international partners for country-specific approvals.Labeling & ComplianceEnsure compliance for labeling, IFUs, UDI, packaging requirements. Preferred Profile6-12+ years in medical device regulatory affairsExperience in multi-country registrationsExposure to US FDA, CE/MDR, CDSCOStrong documentation & coordination skillsExperience in a medical device manufacturing company (preferred)Application Deadline07/31/2026