Executive - Regulatory Affairs & Compliance

Key Responsibilities:

Regulatory Compliance:

• Prepare, submit, and maintain product registrations and licenses.
• Manage documentation for Manufacturing License, Import License, Loan License, and renewals.

Quality & Statutory Requirements:

• Support implementation and maintenance of ISO.
• Coordinate internal audits, CDSCO inspections, and third-party audits.
• Assist in CAPA, deviations, change control, and risk management activities.

Documentation & Labeling:

• Review product labels, IFUs, and packaging for compliance with Indian regulatory requirements.
• Ensure correct classification and conformity to essential principles.
• Maintain device master files, technical documentation, and regulatory records.

Post-Market Surveillance & Vigilance:

• Handle customer complaints, adverse events, and field safety corrective actions.
• Prepare and submit reports.
• Support recalls, market withdrawals, and corrective actions.

Cross-Functional Coordination:

• Work closely with Manufacturing, QA, R&D, Supply Chain, and Sales teams.
• Liaise with CDSCO, State Licensing Authorities (SLA), and authorized agents.

Qualifications & Experience:

• Bachelors / Masters degree in Life Sciences, Pharmacy, or related field.
• 3+ years of experience in medical device regulatory affairs for the Indian market.
• Strong hands-on knowledge of CDSCO regulations and MDR.

Key Skills & Competencies:

• Deep understanding of Indian medical device regulatory framework.
• Strong regulatory documentation and submission skills.
• High attention to detail and compliance orientation.
• Ability to manage multiple licenses, products, and timelines.
• Good communication and coordination skills.