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MJ Surgical, a leading Indian manufacturer of orthopedic implants and medical devices, is hiring a skilled Regulatory Affairs Specialist in Ahmedabad. This is an excellent opportunity for candidates experienced in ISO 13485, EU MDR, CE marking, QMS, risk management, and medical device documentation.
This role is ideal for professionals looking to advance their career in Regulatory Affairs for medical devices, ensuring compliance, product safety, and quality excellence.
Key Responsibilities
- Prepare and manage documentation for ISO 13485 compliance and CE Certification under EU MDR.
- Develop, update, and maintain Technical Master Files (TMF).
- Draft and review Clinical Evaluation Reports (CERs) according to EU MDR guidelines.
- Conduct and implement Risk Management activities as per regulatory standards.
- Manage and maintain Quality Management System (QMS) documentation.
- Communicate with national and international regulatory authorities.
- Conduct internal quality audits and support audit readiness.
- Lead and close the product recall process, ensuring regulatory compliance.
- Maintain accurate, organized, and audit-ready documentation.
Required Skills
- Strong documentation handling and record-keeping skills.
- Excellent written and verbal communication abilities.
- Proficiency in computer applications and MS Office tools.
- Ability to interpret scientific, technical, and legal documents.
Educational Qualifications
Applicants must have one of the following:
- B.Pharm / M.Pharm
- Bachelor’s or Master’s degree in Biomedical Engineering / Science
- Training or certification in Medical Device Regulatory Affairs preferred.
Job Location
📍 Kathwada GIDC, Ahmedabad, Gujarat, India
(On-site, Full-time)
Benefits of Working with MJ Surgical
- Opportunity to work with a globally recognized medical device manufacturer.
- Hands-on exposure to international regulatory pathways (ISO 13485, EU MDR, CE, USFDA).
- Career growth in Regulatory Affairs & Quality Assurance.
- Professional development through audits, documentation, and compliance processes.
How to Apply
