RA Officer – Medical Devices Job in Ahmedabad | MIFAMED

MIFAMED Medical Private Limited is hiring a Regulatory Affairs (RA) Officer – Medical Devices at its Ahmedabad, Gujarat location. This is a full-time, on-site opportunity for professionals with 3–5 years of experience in medical device regulatory affairs, quality systems, and documentation, particularly for Class I and Class II medical devices.

This role offers hands-on exposure to EU MDR, ISO 13485, CE marking, EUDAMED, and global regulatory frameworks—ideal for candidates seeking long-term growth in the medical devices regulatory affairs domain.

🔍 Job Overview

• Job Title: RA Officer – Medical Devices
• Company: MIFAMED Medical Private Limited
• Location: Ahmedabad, Gujarat, India
• Job Type: Full-time | On-site
• Experience Required: 3–5 years
• Industry: Medical Devices | Regulatory Affairs | Quality Assurance

🧾 Key Responsibilities – RA Officer Medical Devices

• Maintain and update product databases including EUDAMED and Ministry of Health portals
• Review and manage regulatory documents: CE, ISO 13485, DoC, FSC, IFU, PMS, CER, UDI
• Verify CE and ISO certificates with issuing and notified bodies
• Perform supplier qualification and desktop evaluation of manufacturers
• Develop, review, and maintain SOPs and work instructions ensuring long-term data integrity
• Coordinate with QA, Purchase, and Sales teams to resolve product-related regulatory issues
• Support continuous improvement initiatives within the Quality Management System (QMS)

🎓 Qualifications & Skills Required

• Bachelor’s or Master’s degree in:
  • Life Sciences
  • Regulatory Affairs
  • Pharmacy
  • Biomedical Engineering
• Minimum 3 years of hands-on experience with Class I & II medical devices
• Strong working knowledge of:
  • ISO 13485
  • EU MDR
  • CE Marking
  • Global QMS requirements
• Proven experience in regulatory and technical document review
• Excellent English communication skills (written & verbal)
• Proficiency in MS Word, Excel, and PowerPoint
• Detail-oriented, self-driven, and capable of managing multiple regulatory projects
• Willingness to commit for a minimum of 3 years

🌍 Why Join MIFAMED Medical?

• Exposure to global medical device regulatory frameworks
• Opportunity to work in a multicultural, international environment
• Strong focus on professional development and career growth
• Potential for international travel
• Be part of a mission-driven organization delivering safe and compliant medical devices worldwide

📩 How to Apply

Application Link