Looking to start your career in Regulatory Affairs for Medical Devices? Saraca Solutions is hiring a Quality and Regulatory Affairs Specialist in Noida for fresh B.Tech Biotechnology graduates. This opportunity is ideal for candidates interested in EU MDR, US FDA, and CDSCO medical device regulations, technical documentation, and medical writing.
With rising demand for medical device regulatory compliance professionals, this entry-level regulatory affairs job offers exposure to global regulatory frameworks and clinical documentation standards.
📌 Job Overview
- Company: Saraca Solutions
- Role: Quality and Regulatory Affairs Specialist
- Location: Noida, Delhi NCR
- Industry: IT Services & Consulting (Medical Devices Regulatory)
- Employment Type: Full-Time, Permanent
- Experience: 0–1 Year (Freshers Eligible)
- Salary: ₹2.75 – ₹3.25 LPA
🔬 Key Responsibilities
The Quality and Regulatory Affairs Specialist will:
- Ensure regulatory compliance for medical devices across EU, India, and US markets
- Support preparation of technical documentation and regulatory submissions
- Assist in medical writing activities including clinical evaluation reports (CER)
- Contribute to EU MDR and US FDA regulatory filings
- Support documentation aligned with ISO 13485 and QMS requirements
- Maintain compliance with CDSCO, EU MDR, and US FDA guidelines
- Coordinate regulatory strategy and lifecycle management activities
This role provides foundational exposure to medical device regulatory affairs, making it ideal for biotechnology graduates entering the regulatory domain.
🎓 Qualifications Required
- B.Tech in Biotechnology (Fresher)
- Basic understanding of medical device regulations (EU, US, India)
- Knowledge of regulatory documentation and compliance frameworks
- Strong documentation and technical writing skills
- Attention to detail and analytical mindset
Candidates interested in medical writing jobs in Noida, regulatory compliance careers, and EU MDR roles will find this opportunity relevant.
💼 Why Join Saraca Solutions?
- Exposure to global medical device regulatory frameworks
- Hands-on experience in regulatory submissions
- Opportunity to build a career in Regulatory Affairs & Medical Writing
- Growing IT and regulatory consulting environment
- Structured learning in EU MDR, US FDA, and CDSCO compliance
📥 How to Apply
