Regulatory Affairs Specialist For Medical Devices

Roles & Responsibilities:
• Prepare and manage documentation for ISO 13485 certification, CE marking (EU MDR), and USFDA submissions
• Develop and maintain Technical Master Files for medical device products
• Create and update Clinical Evaluation Reports (CERs) as per EU MDR requirements
• Handle Design & Development documentation along with Risk Management files in compliance with EU MDR guidelines
• Maintain and implement Quality Management Systems (QMS) for medical devices
• Prepare and submit regulatory dossiers to authorities in India, Europe, and the US
• Conduct internal quality audits to ensure ongoing regulatory compliance
• Ensure compliance with European CE regulations (MDD & MDR) and USFDA 510(k) pathways
• Monitor regulatory updates and implement necessary changes in documentation and processes

Qualification:
• B.Pharm (Bachelor of Pharmacy) / M.Pharm (Bachelor of Pharmacy) or Bachelor’s / Master’s degree in Biomedical Engineering or relevant Science discipline
• Specialized training in Medical Devices Regulatory Affairs preferred

Experience:
• 3–5 years of experience in regulatory affairs for medical devices (mandatory)

Skills:
• Strong knowledge of European CE marking (MDD & MDR) requirements
• Hands-on experience with USFDA 510(k) submission process
• In-depth understanding of Quality Management Systems (ISO 13485)
• Excellent documentation and technical writing skills
• Strong written and verbal communication abilities
• Proficiency in MS Office and regulatory documentation tools
• High attention to detail and compliance-oriented mindset

About the Organization:
MJ Surgical is a leading manufacturer and exporter of orthopedic implants and instruments, committed to delivering high-quality medical devices that meet global regulatory standards and support international market access.