Lead Consultant - Regulatory Engineer

Collaborate with cross functional teams (engineering, manufacturing, regulatory, sourcing, etc.) to lead or support compliance activities to medical device regulations.

Review regulatory compliance change notifications and drive associated actions to be compliant by the effective date

Lead compliance efforts to various global regulations (E.g. REACH, ROHS, etc.) in alignment with the quality management system

Lead or support product regulatory documentation updates (e.g. NRTL reports, tech file, etc.)

Support regulatory audits and inspections to ensure post-market surveillance compliance.

Knowledge of medical regulations including FDA, EU MDR, NMPA/CFDA, and other applicable international regulations

Knowledge of regulatory standards such as IEC 60601, ISO13485, 14971 and other applicable standards and substandard.

Proficiency in interpreting, applying complex regulations, and preparing associated documentation.

Excellent interpersonal communication and collaboration skills

About Company

Genpact is a global professional services firm that offers a wide range of digital transformation services and solutions. With a presence in over 30 countries, Genpact leverages its deep domain expertise in operations and analytics to help businesses transform their operations, improve efficiency, and enhance customer experience. The company combines digital technology, data science, and operational excellence to deliver business outcomes across various industries, including banking, insurance, manufacturing, and healthcare. Founded in 1997 as a subsidiary of GE, Genpact has grown into an independent, NYSE-listed company with a diverse workforce of over 90,000 employees globally.