Manager – Global Regulatory Affairs

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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.).
Prepare and submit dossiers (CDSCO, US FDA, CE/MDR, MOHAP, PMDA, COFEPRIS, etc.).
Manage technical documentation (Technical File, STED, DMF, CER, etc.).
Track approvals, renewals,



and post-market variations.Regulatory StrategyDefine registration pathways for new products and markets.Provide regulatory feasibility inputs during product selection / OEM onboarding.Optimize timelines and cost for registrations globally.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.
xysqume Align regulatory documentation with market-specific 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
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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7ggxc5