Manager – Global Regulatory Affairs
Pubblicato il 04-08-2026 - Altro in Bolzano Vicentino
The Global Regulatory Affairs Lead is responsible for end-to-end product registrations and regulatory strategy across multiple geographies.
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Leadership Tempo pieno Onsite
Experience Required
7.0 - 10.0 Years
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. xkiyazw
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