Manager, Regulatory Affairs

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7fbpy3

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
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
Manage technical documentation (Technical File, STED, DMF, CER, etc.).
Define registration pathways for new products and markets.




Provide regulatory feasibility inputs during product selection / OEM onboarding.
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.
Preferred Profile 6-12+ years in medical device regulatory affairs
Experience in multi-country registrations
Experience in a medical device manufacturing company (preferred)

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7fbpy3