Role & responsibilities

Client-Centric Regulatory Leadership:

- Serve as the regulatory lead for strategic customer accounts, ensuring alignment with client-specific

compliance requirements.

- Act as a trusted advisor to clients on global regulatory pathways, documentation, and risk mitigation

strategies.

Global Regulatory Strategy & Execution:

- Develop and implement regulatory strategies for product development, submissions, and lifecycle

management across geographies (US, EU, India, APAC).

- Ensure compliance with applicable standards and regulations including FDA 21 CFR, EU MDR/IVDR, ISO

13485, IEC 62304, and ISO 14971.

Program Oversight & Governance:

- Lead regulatory planning and execution across multiple concurrent projects.
- Establish and maintain regulatory documentation, audit readiness,



and quality systems in line with both

Tata Elxsi and client expectations.

Cross-Functional Collaboration:

- Collaborate with engineering, quality assurance, clinical, and legal teams to ensure regulatory alignment

throughout the product lifecycle.

- Facilitate regulatory training and awareness across internal teams working on customer programs.

Innovation & Compliance:

- Support regulatory strategy for emerging technologies including AI/ML-enabled devices, connected health

platforms, and cloud-based solutions.

- Monitor evolving regulatory landscapes and proactively guide clients and internal teams on implications.

📌 Opening For Program Director/Manager Healthcare & Life Sciences (Pune)
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📍 Pune