MJ Surgical hiring for Regulatory Affairs Specialist job role | biomedical engineering jobs | Apply Now
Seeking a career in regulatory affairs specialist roles? MJ Surgical in Ahmedabad offers a hands-on opportunity for candidates from biomedical engineering and life sciences backgrounds. Join our team to manage regulatory submissions, maintain ISO 13485 and CE certification documents, support USFDA 510(k) filings, and ensure compliance with medical device regulations. Perfect for professionals looking for biomedical engineering jobs to grow their life science career in the medical device industry
- Job Title: Regulatory Affairs Specialist
- Location: Kathwada GIDC, Ahmedabad
About the Company:
MJ Surgical is a leading innovator in the medical device industry, committed to enhancing healthcare solutions through advanced research and development. Our dedication to quality and compliance has positioned us at the forefront of medical advancements, providing reliable and effective products worldwide. Join us in our mission to transform patient care through excellence in design and function.
Job Description:
MJ Surgical, Ahmedabad, is hiring a regulatory affairs specialist for candidates with a biomedical engineering or life sciences background. The role involves managing regulatory documentation, ensuring compliance with ISO 13485, CE Certification, and USFDA 510(k) standards, and supporting QMS and clinical evaluation activities. Ideal
for professionals looking to grow their life science career in medical devices.Salary:
- Freshers: Up to ₹25,000 per month
- 1–2 Years Experience: Up to ₹35,000 per month
- 2+ Years Experience: Salary as per experience and interview performance
Key Responsibilities:
- Preparation and maintenance of documents for ISO 13485 and CE Certification (as per EU MDR)
- Handling documentation related to USFDA 510(k) submissions
- Preparation and maintenance of Technical Master Files (TMF)
- Preparation of Clinical Evaluation Reports (CERs) as per EU MDR
- Implementation and maintenance of Quality Management Systems (QMS)
- Reporting and coordination with regulatory authorities
- Conducting internal quality audits
- Initiating and closing the product recall process
- Supporting activities related to Risk Management and Clinical Evaluation
Educational requirements:
- Bachelor’s or Master’s Degree in Biomedical Engineering or Science Discipline
- Training in medical device regulatory affairs will be an added advantage
Skills Required:
- Strong documentation handling skills
- Proficiency in computer applications and MS Office
- Knowledge of medical device regulations (India, EU, US)
- Understanding of risk management and clinical evaluation
- Excellent written and verbal communication
This is an excellent opportunity for motivated life sciences and biomedical engineering professionals to advance their careers. Join MJ Surgical as a Regulatory Affairs Specialist and gain hands-on experience in regulatory compliance, quality management, and clinical processes.
