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Freshers Regulatory Associate Jobs at Malu Healthcare Pvt. Ltd
Freshers Regulatory Associate Jobs at Malu Healthcare Pvt. Ltd are now open for candidates looking to begin their careers in medical device regulatory affairs and quality management systems. This opportunity is ideal for recent graduates and early-career professionals who want hands-on exposure to ISO 13485 compliance, QMS documentation, internal audits, and regulatory processes within a rapidly growing healthcare organization.
Job Role: Regulatory Associate
Company: Malu Healthcare Pvt. Ltd.
Location: Kanjurmarg East, Mumbai – 400042
Position Type: Full-time
Experience: 0–1 year (6-month internship also considered)
Salary Range: ₹15,000 – ₹30,000 per month (based on knowledge &
experience)
Company Description
Malu Healthcare Pvt. Ltd. is a rapidly growing medical device organization committed to
delivering high-quality and innovative healthcare solutions. With a strong focus on
compliance, quality, and safety, the company is dedicated to maintaining robust Quality
Management Systems in line with ISO 13485:2016 standards.
Role Overview
We are seeking a detail-oriented and proactive ISO 13485 Regulatory Associate to support QMS activities, manage documentation, coordinate internal audits, and ensure adherence to ISO 13485:2016 regulatory requirements. The ideal candidate should have a strong understanding of QMS & QSP documentation and a keen interest in regulatory affairs within the medical device industry.
Key Responsibilities
ISO 13485 Documentation & Compliance
• Manage, update, and maintain ISO 13485:2016 documentation.
• Ensure effective implementation and continuous improvement of the Quality Management
System.
• Assist in ensuring organizational compliance with ISO 13485 and regulatory requirements.
Internal Audits & Quality Processes
• Support planning, execution, and documentation of internal audits.
• Assist in tracking non-conformities, CAPA, and change control activities.
• Coordinate with various departments to close audit findings and ensure corrective actions.
QMS & QSP Documentation Management
• Prepare, review, and maintain Quality System Procedures (QSPs), records, logs, and related
quality documents.
• Ensure document control, version management, and compliance with quality standards.
Cross-functional Collaboration
• Work closely with QA, RA, Production, and other teams to support quality initiatives.
• Assist in regulatory documentation and submissions as required.
• Participate in quality meetings, trainings, and process improvement activities.
Qualifications
• Bachelor’s or Master’s degree, Biotechnology, Life Sciences, Pharmacy
(B.Pharm/M.Pharm)
• Strong knowledge of ISO 13485:2016 standard.
• Experience or internship exposure in QMS & QSP documentation.
• Understanding of medical device regulatory requirements and compliance processes.
• Good analytical, communication, and documentation skills.
• Ability to work collaboratively with cross-functional teams.
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