Opening For Program Director/Manager Healthcare & Life Sciences

Staffing Services; Pune District; Sur place; INR 1 800 000 - 3 000 000; Plein temps

Résumé du poste

Staffing Services seeks a Regulatory Lead to guide client accounts through global regulatory pathways, ensuring alignment with compliance requirements across markets. You will develop and execute regulatory strategies for product development, submissions, and lifecycle management across US, EU, India and APAC, while ensuring adherence to FDA 21 CFR, EU MDR/IVDR, ISO 13485, IEC 62304 and ISO 14971.

Collaborating with engineering, QA, clinical and legal teams, you will drive audit readiness,

Qualifications

• Regulatory leadership experience for key customer accounts.
• Advising clients on global regulatory pathways, documentation, and risk mitigation.

Responsabilités

• Lead regulatory planning and execution for multiple projects.
• Ensure compliance with FDA 21 CFR, EU MDR/IVDR, ISO 13485, IEC 62304, ISO 14971.

Description du poste

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.