Are you looking to start your career in Quality Assurance and Regulatory Affairs (QARA) in the medical device industry? A promising opportunity is now open for a QARA Associate in Pune for candidates with up to 1 year of experience.
This role is ideal for freshers or early-career professionals aiming to build expertise in ISO 13485, CDSCO regulations, CAPA, and medical device compliance. If you have a keen eye for detail and strong documentation skills, this position can serve as a solid entry point into regulatory careers.
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🔍 Job Overview
- Job Title: QARA Associate
- Location: Pune, Maharashtra, India
- Experience: 0–1 Year
- Industry: Medical Devices / Regulatory Affairs / Quality Assurance
- Employment Type: Full-Time
🛠️ Key Responsibilities
As a QARA Associate, you will support critical quality and regulatory functions, including:
- Assisting in implementation and maintenance of QMS as per ISO 13485:2016
- Managing controlled documentation, ensuring traceability and compliance
- Supporting CDSCO regulatory submissions and compliance activities
- Participating in risk management processes (ISO 14971)
- Assisting with Design History File (DHF) and Verification & Validation (V&V) documentation
- Supporting internal and external audits, including CAPA implementation
- Contributing to IEC 62304 software lifecycle compliance
🎓 Qualifications & Skills
Educational Requirements:
- Bachelor’s degree in Pharmacy, Life Sciences, Biomedical Engineering, or related field
Required Skills:
- Basic understanding of Quality Assurance and Regulatory Affairs
- Knowledge of ISO 13485, CDSCO guidelines, and CAPA processes
- Strong documentation and organizational skills
- High attention to detail and compliance-oriented mindset
- Good communication and coordination abilities
- Analytical thinking and problem-solving approach
💼 Why This QARA Job is a Great Opportunity
- Entry-level opportunity in medical device regulatory affairs
- Hands-on exposure to ISO standards and CDSCO regulations
- Experience with audit preparation and CAPA systems
- Career growth in quality assurance and compliance roles
- Opportunity to work in a structured and regulated environment
💰 Salary Insight
- Estimated Salary Range: ₹2.5 LPA – ₹4 LPA (based on industry standards for entry-level QARA roles in Pune)
📩 How to Apply
Interested candidates can apply by sending their updated resume to: