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 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)
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