Manager - global regulatory affairs

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

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 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. 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

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