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RA & QA Jobs Life Sciences at MedPrime Technologies, Apply on Biotecnika
Looking for RA & QA Jobs in Life Sciences? Here’s an exciting opportunity at MedPrime Technologies for professionals aiming to build a career in Regulatory Affairs and Quality Assurance within regulated industries.
RA & QA Jobs Life Sciences at MedPrime Technologies, Apply on Biotecnika to explore a full-time role designed for early-career candidates seeking hands-on experience with regulatory documentation, QMS, and compliance in medical devices and laboratory equipment.
Job Title: Regulatory Affairs & Quality Assurance (RA & QA) Executive
Company: MedPrime Technologies
Location: Thane, Maharashtra
Employment Type: Full-time
Experience Required: 1–3 years
Salary Range: Up to ₹40,000 per month
Job Summary
MedPrime Technologies is seeking a detail-oriented Regulatory Affairs & Quality
Assurance (RA & QA) Executive to support regulatory and quality activities for laboratory
equipment and/or medical devices.
The role involves assisting with regulatory documentation, quality management system
(QMS) maintenance, compliance activities, and coordination with cross-functional teams to
ensure products meet applicable regulatory and quality requirements. This position is ideal
for early-career professionals looking to build expertise in regulated industries.
Key Responsibilities
• Assist in preparation, compilation, and maintenance of regulatory documentation such as
Technical Files, Device Master Records (DMR), and product dossiers
• Support product registrations, renewals, and variations under applicable regulations
(CE, FDA, CDSCO, or local regulations) under supervision
• Assist in regulatory submission tracking, timelines, status reporting, and documentation
control
• Support internal audit preparation, execution, and follow-up activities
• Assist with labelling, IFU, and packaging compliance reviews
• Monitor regulatory updates and support impact assessment on existing products
• Coordinate with R&D, Production, QA, and cross-functional teams to gather regulatory
and quality inputs
• Support external audits and inspections conducted by certification bodies and regulatory
authorities
• Maintain regulatory records, databases, and document repositories
• Assist in creation, review, and control of SOPs, work instructions, formats, and quality
records
• Support implementation and maintenance of the Quality Management System (QMS) in
line with ISO 9001 and ISO 13485
• Support deviation management, non-conformance reporting, CAPA, and change
control documentation
• Assist in risk management documentation, product quality reviews, and supplier quality
activities
• Support validation, calibration, and equipment qualification documentation
• Maintain training records and support compliance with training requirements
• Support departmental objectives and tasks assigned by the reporting manager
Required Qualifications
• Bachelor’s degree in Life Sciences, Biomedical Engineering, Biotechnology, Pharmacy,
Chemistry, or a related field
• 1–3 years of experience or relevant internship exposure in Regulatory Affairs, Quality
Assurance, or regulated industries
• Basic understanding of:
– ISO 9001 / ISO 13485 standards
– Regulatory requirements for medical devices or laboratory equipment
– Documentation practices and quality systems
• Good written and verbal communication skills
• Strong attention to detail and organizational skills
Preferred Skills & Experience
• Exposure to CE Marking, FDA, CDSCO, or other regional regulatory frameworks
• Familiarity with audits and regulatory inspections
• Understanding of risk management standards
• Experience with document management systems (DMS)
• Ability to work collaboratively in a cross-functional environment
