Freshers Job – Regulatory Affairs Specialist Job at MJ Surgical
MJ Surgical is hiring a Regulatory Affairs Specialist for its Kathwada GIDC, Ahmedabad location. This Regulatory Affairs Job role is ideal for freshers and experienced candidates looking to build a strong career in medical device regulations, ISO standards, CE certifications, and USFDA documentation. With competitive salaries and excellent learning opportunities, this position offers a path to grow within the regulatory affairs domain. Graduates seeking B Pharma jobs or M Pharma jobs can apply now.
Job Details
- Job Title: Regulatory Affairs Specialist
- Location: Kathwada GIDC, Ahmedabad
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
Job Description
- 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
Job Requirements
- Strong documentation handling skills
- Good written and verbal communication skills
- Proficiency in Computer Applications and MS Office
- Knowledge of Risk Management, Clinical Evaluation, and Medical Device Regulations
- Understanding of Regulatory Guidelines for Medical Devices (India, EU, US)
Educational Qualification
- B.Pharm / M.Pharm
- Training in Medical Devices Regulatory Affairs will be an added advantage
Why This Job Role?
This Regulatory Affairs Job role offers hands-on experience across global regulatory frameworks, including EU MDR, ISO 13485, and USFDA 510(k). It is ideal for candidates aiming to build a long-term career in Regulatory Affairs with exposure to key documentation, QMS, and medical device submissions. Graduates seeking B Pharma jobs or M Pharma jobs can apply now.