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Opening For Program Director/Manager Healthcare & Life Sciences

Opening For Program Director/Manager Healthcare & Life Sciences

Staffing Services

13 - 15 years

30 - 45 Lacs

pune

Posted:1 week ago| Platform:

Apply

Skills Required

program management oems stakeholder management

Work Mode

Work from Office

Job Type

Full Time

Job Description

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.

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