Position - Senior Executive Quality Assurance & Regulatory Affairs

Location: Sector -34, Gurugram

About Company -

Vygon ,is French based multinational company, Founded in 1962 in couen, has gradually expanded across all five continents. After building strong foundations in Europe, the group extended its presence to North and South America, and later to the Middle East and Asia. Today, Vygon relies on 26 subsidiaries, 11 production sites including 8 in Europe and the dedication of more than 2750 team members, who provide nearly 210 million medical devices each year for 4,000 customers. Vygon designs, manufactures and markets high-tech single-use medical devices for healthcare professionals.

website - https://www.vygon.com/en

Products Segment - Vascular, Aneasthesia, Neonates, Vascular, Hemodynamics , Critical Care,

Role Overview:

The role will be supporting product integrity and regulatory excellence. You will bridge the gap between complex global standards and local operational execution, ensuring that every product reaching a patient is secure, compliant, and of the highest quality. This role is pivotal in managing our Quality Management System (QMS) across our supply chain, including 3PL oversight and post-market surveillance.

Key Responsibilities:

1. Quality Management & Compliance (QMS)

- Design, implement, and refine QA programs and controls tailored to the medical device lifecycle.
- Ensure continuous audit readiness by leading and facilitating internal and external audits (e.g., Notified Bodies, CDSCO), maintaining complete and compliant documentation at all times.
- Drive Non-Conformance and CAPA processes, including investigation of deviations, root cause analysis,



and implementation of corrective and preventive actions.

2. Operational & 3PL Oversight

- Enforce robust inventory governance, including FIFO/FEFO implementation and climate-control monitoring to ensure product efficacy.
- Manage the quality aspect of service and repairs, ensuring returned goods are handled per regulatory standards.

3. Regulatory & Sustainability Affairs

- Monitor and ensure adherence to EPR (Extended Producer Responsibility) and CPCB guidelines Manage Adverse Event (AE/SAE) reporting, product tampering investigations, and anti-counterfeiting measures
- Coordinate safety communications and lead execution for product recalls or field safety corrective actions (FSCA).

4. Stakeholder & Supplier Management

- Monitor supplier performance through periodic audits and compliance scorecards.
Partner with Logistics, Sales, and Global HQ to streamline operational excellence and inventory accuracy.

Key Requirements:

Education:

- Bachelors degree in pharmacy, Life Sciences, Biomedical Engineering, or related discipline.

Experience:

- Minimum 3 years of experience in Quality Assurance in medical devices or pharmaceuticals industry.
- Must have Knowledge and understanding of MDR2017 and D&C; Act 1940 & Rules 1945 Legal Metrology.

Skills & Competencies:

- Strong knowledge of Indian medical device regulations and ISO 13485.
- Experience in audit handling, documentation control, and CAPA.
- Good understanding of warehousing, distribution, and inventory controls.
- Strong coordination, communication, and stakeholdermanagement skills.
- Ability to work independently with a proactive and compliancedriven approach.

📌 Senior Executive - Quality Assurance, Medical Devices (Gurugram)
🏢 vygon india
📍 Gurugram