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Medical Device Regulatory Affairs & QA Roles
Maven Profcon
Ahmedabad
Freshers +
RA / QA
Medical Devices
🏢 About Company
Maven Profcon Services LLP is a global regulatory consulting firm specializing in medical device approvals across US, EU, and UK markets. The company supports international clients in achieving compliance with US FDA, EU MDR, and ISO standards.
1️⃣ Junior Regulatory Executive (US FDA / EU MDR)
📌 Key Responsibilities:- Prepare regulatory documents (CER, RMF, PMS)
- Support US FDA 510(k) submissions
- Assist in EU MDR 2017/745 & CE certification
- Maintain regulatory documentation
- Track global regulatory updates
- Knowledge of US FDA 510(k)
- Understanding of EU MDR regulations
- Regulatory writing skills
2️⃣ Junior QA Executive
📌 Key Responsibilities:- Ensure ISO 13485 QMS compliance
- Document control & audit preparation
- Support risk management processes
- Assist in internal & external audits
- Knowledge of ISO 13485
- Quality systems & documentation
- Attention to detail
🎓 Eligibility
- Bachelor’s in Life Sciences / Biomedical Engineering / Regulatory Affairs
- Freshers with relevant training OR 6+ months experience
💰 Salary (Estimated)
- ₹3.5 LPA – ₹6 LPA
🚀 Career Growth
- Regulatory Affairs Specialist
- Medical Device Consultant
- QA/QMS Auditor
- Global Regulatory Expert
🎯 Interview Tips
For Regulatory Role:- Revise US FDA 510(k) basics
- Understand EU MDR structure
- Learn CER & PMS concepts
- Understand ISO 13485 clauses
- Revise audit process & documentation
- Learn QMS basics
📚 Helpful Resources:
📌 Note Before You Apply:
Freshers with training in Medical Device Regulatory Affairs or QA have higher chances of selection.
Freshers with training in Medical Device Regulatory Affairs or QA have higher chances of selection.
👇 Apply Here 👇
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