Executive – Regulatory Affairs

Job Description

We are hiring an Executive – Regulatory Affairs for a medical device company.

The candidate will be responsible for regulatory submissions, documentation, and compliance.

Key Responsibilities

• Prepare and submit regulatory dossiers (ACTD, CTD modules, ANDA).
• Handle product registration across India and international markets.
• Manage regulatory submissions for USFDA, EU MDR, and other global authorities.
• Coordinate clinical trial documentation and regulatory approvals.
• Develop and implement global regulatory strategies.
• Maintain regulatory documentation and records.
• Ensure compliance with applicable regulatory guidelines.
• Coordinate with internal teams for product approvals and audits.

Required Skills

• Strong experience in regulatory affairs for medical devices or pharma.
• Knowledge of ACTD, CTD modules, ANDA submissions.
• Experience with USFDA, EU MDR, and international regulations.
• Understanding of clinical trial and registration processes.
• Strong documentation and analytical skills.
• Good communication and coordination abilities.