Regulatory Affairs Specialist Job for Medical Devices at MJ Surgical in Ahmedabad. Medical device regulatory job with EU MDR and USFDA compliance experience required India.
MJ Surgical is currently hiring Regulatory Affairs Specialists for its medical device division in Ahmedabad, Gujarat. This opportunity is ideal for professionals with experience in medical device regulatory compliance and international certifications. The role focuses on global regulatory submissions, technical documentation, and compliance with standards such as EU MDR, USFDA, and ISO 13485.
If you are passionate about regulatory affairs in the medical devices industry and want to work with an orthopedic implant manufacturer serving global markets, this role offers strong career growth potential. Regulatory Affairs Specialist Job for Medical Devices at MJ Surgical
Company Overview
MJ Surgical is a well-established manufacturer and exporter specializing in orthopedic implants and surgical instruments. The company has built a strong reputation for delivering high-quality medical devices that meet international regulatory and quality standards.
With certifications aligned to global regulatory frameworks, MJ Surgical supplies products to multiple international markets and continues to expand its footprint in the orthopedic medical device sector. Regulatory Affairs Specialist Job for Medical Devices at MJ Surgical
Job Location & Employment Type
- Job Title: Regulatory Affairs Specialist – Medical Devices
- Company: MJ Surgical
- Location: Ahmedabad, Gujarat
- Employment Type: Full-Time
- Application Mode: Online Application
- Experience Level: Mid-level (3–5 years)
This is an office-based role suitable for professionals with hands-on regulatory documentation experience.
Department Details
The position falls under the Regulatory Affairs and Quality Compliance department. The selected candidate will be responsible for managing regulatory documentation and supporting product approvals across domestic and international markets.
The role involves close coordination with quality, R&D, and manufacturing teams to ensure regulatory readiness throughout the product lifecycle. Regulatory Affairs Specialist Job for Medical Devices at MJ Surgical
Key Roles & Responsibilities
As a Regulatory Affairs Specialist, you will manage documentation and compliance processes for medical devices. Key responsibilities include:
- Preparing and managing regulatory documentation for global certifications
- Supporting ISO 13485 certification processes
- Handling CE marking documentation in line with EU MDR requirements
- Preparing and maintaining Technical Master Files (TMF)
- Developing Clinical Evaluation Reports (CERs) for medical devices
- Managing design and development documentation
- Preparing risk management files as per regulatory standards
- Maintaining and improving Quality Management Systems (QMS)
- Preparing regulatory submissions for India, Europe, and the United States
- Conducting internal audits to ensure ongoing compliance
- Monitoring changes in global medical device regulations
- Supporting USFDA 510(k) submission documentation
- Coordinating with cross-functional teams for regulatory updates
This role requires strong documentation skills and up-to-date knowledge of global device regulations. Regulatory Affairs Specialist Job for Medical Devices at MJ Surgical
Eligibility Criteria
Education
Candidates must have one of the following qualifications:
- B.Pharm or M.Pharm
- Bachelor’s or Master’s degree in:
- Biomedical Engineering
- Life Sciences
- Relevant scientific disciplines
Specialized training in medical device regulatory affairs will be an added advantage.
Experience
- 3–5 years of regulatory affairs experience in the medical devices sector (mandatory)
- Experience with global regulatory submissions preferred
Candidates with orthopedic or implant regulatory exposure will have an advantage. Regulatory Affairs Specialist Job for Medical Devices at MJ Surgical
Skills Required
Applicants should possess the following competencies:
- Strong regulatory documentation skills
- Excellent written and verbal communication
- Knowledge of global medical device regulations
- Familiarity with EU MDR and CE marking processes
- Understanding of USFDA 510(k) submission pathways
- Experience with Quality Management Systems (QMS)
- Attention to detail and regulatory accuracy
- Proficiency in MS Office tools
- Ability to manage multiple regulatory projects
Candidates should be comfortable handling technical documentation and compliance audits.
Salary & Benefits
- Salary Range: ₹30,000 – ₹80,000 per month (based on experience)
- Additional benefits may include:
- Provident Fund (PF)
- Leave encashment
- Annual performance bonus
- Career growth in the medical device industry
The final compensation will depend on qualifications and interview performance.
Selection Process
The hiring process generally includes:
- Online application submission
- Resume screening
- Technical interview (Regulatory focus)
- HR discussion and final offer
Candidates should be prepared to discuss regulatory documentation experience. Regulatory Affairs Specialist Job for Medical Devices at MJ Surgical
How to Apply
Interested candidates can apply through the company’s official channels or LinkedIn.
Application tips:
- Update your resume with medical device regulatory experience
- Highlight certifications and regulatory submissions handled
- Include exposure to ISO, CE, or USFDA processes
Shortlisted candidates will be contacted by the hiring team for further steps.
Important Dates
- Application Deadline: Not specified
Candidates are advised to apply early due to limited openings.
Why Apply for This Pharma Job?
This opportunity offers several benefits for regulatory professionals:
- Work with a growing orthopedic medical device manufacturer
- Exposure to international regulatory frameworks
- Hands-on experience with CE and USFDA submissions
- Strong growth opportunities in the medical device sector
- Competitive salary for mid-level professionals
- Opportunity to build expertise in global compliance
If you are looking to specialize in medical device regulatory affairs, this role provides excellent practical exposure. Regulatory Affairs Specialist Job for Medical Devices at MJ Surgical
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent platform providing pharmaceutical and medical device job updates for informational purposes. We are not affiliated with MJ Surgical. Candidates should verify all details through official company sources before applying.
Applicants should remain cautious of fraudulent recruitment practices and apply only through trusted channels. Regulatory Affairs Specialist Job for Medical Devices at MJ Surgical
Final Words
Regulatory roles in the medical device sector are in high demand, especially for professionals with EU MDR and USFDA knowledge. If you have 3–5 years of experience in medical device regulatory affairs, this opportunity at MJ Surgical could help accelerate your career. Update your resume, highlight your regulatory expertise, and apply at the earliest to improve your chances of selection. Regulatory Affairs Specialist Job for Medical Devices at MJ Surgical
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