Manager – global regulatory affairs

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PpThe Global Regulatory Affairs Lead is responsible for end-to-end product registrations and regulatory strategy across multiple geographies. /ppLeadership Tempo pieno Onsite /ph3Experience Required /h3p7.0 - 10.0 Years /ph3Job Description /h3pThe Global Regulatory Affairs Lead is responsible for end-to-end product registrations and regulatory strategy across multiple geographies. /ppThis role ensures that all Taevas products meet country-specific regulatory requirements and are approved for market entry in a timely and compliant manner. /ph3Key Responsibilities /h3ulliGlobal Product Registrations /liliLead regulatory submissions across key markets (India, US, EU, UAE, LATAM, APAC, etc.). /liliPrepare and submit dossiers (CDSCO, US FDA, CE/MDR, MOHAP, PMDA, COFEPRIS, etc.). /liliManage technical documentation (Technical File, STED, DMF, CER, etc.). /liliTrack approvals, renewals, and post-market variations. /liliRegulatory Strategy /liliDefine registration pathways for new products and markets.



/liliProvide regulatory feasibility inputs during product selection / OEM onboarding. /liliOptimize timelines and cost for registrations globally. /liliStakeholder Agency Management /liliLiaise with Notified Bodies, regulatory consultants, labs, and local agents. /liliCoordinate with international partners for country-specific approvals. /liliLabeling Compliance /liliEnsure compliance for labeling, IFUs, UDI, packaging requirements. /liliAlign regulatory documentation with market-specific requirements. /li /ulh3Preferred Profile /h3ulli6-12+ years in medical device regulatory affairs /liliExperience in multi-country registrations /liliExposure to US FDA, CE/MDR, CDSCO /liliStrong documentation coordination skills /liliExperience in a medical device manufacturing company (preferred) /li /ulh3Application Deadline /h3p07/31/2026 /p /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7f8jep