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
- 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-18808-Ljbffr

📌 Manager – Global Regulatory Affairs (Monteviale)
🏢 Taevas Life Sciences
📍 Monteviale