The Global Regulatory Affairs Lead is responsible for end-to-end product registrations and regulatory strategy across multiple geographies.
Leadership Tempo pieno Onsite
Experience Required
********** Years
Job Description
The 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 Responsibilities Global Product Registrations Lead 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 Strategy Define 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 Management Liaise with Notified Bodies, regulatory consultants, labs, and local agents.
Coordinate with international partners for country-specific approvals.
Labeling & Compliance Ensure compliance for labeling, IFUs, UDI, packaging requirements.
Align regulatory documentation with market-specific requirements.
Preferred Profile 6-12+ years in medical device regulatory affairs Experience in multi-country registrations Exposure to US FDA, CE/MDR, CDSCO Strong documentation & coordination skills Experience in a medical device manufacturing company (preferred) Application Deadline
07/31/2026 #J-*****-Ljbffr

📌 Manager – Global Regulatory Affairs (Campo di Ne)
🏢 Taevas Life Sciences
📍 Campo di Ne