Regulatory Affairs Manager

Job Title: Regulatory Affairs Manager

Key Responsibilities:

• Prepare and submit applications for CDSCO (Form MD-14/MD-15), USFDA 510(k), BIS registration, and CE Marking.
• Manage regulatory audits and inspections (USFDA, CE, ISO 13485, BIS).
• Ensure compliance with 21 CFR 820 (USFDA), EU MDR 2017/745 (CE), Indian MDR 2017 (CDSCO), and BIS standards.
• Review technical files, labeling, and promotional material for regulatory compliance.
• Monitor regulatory changes globally and advise internal teams.
• Support post-market surveillance, reporting, and product registrations.
  

Requirements:

• Bachelors/Master’s degree in Pharmacy, Life Sciences, Biomedical, or related field.
• 7–10 years of regulatory affairs experience in medical devices.
• Strong knowledge of CDSCO processes, USFDA 510(k), CE Technical Files, and BIS requirements.
• Audit handling experience (domestic and international).
• Strong documentation, analytical, and communication skills.