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ELEXES Medical Consulting Pvt. Ltd. is hiring Project Associate I – Regulatory Affairs & Quality Assurance (RA/QA) professionals to support global medical device regulatory submissions. This opportunity is ideal for fresh graduates and early-career candidates looking to build a strong foundation in medical device regulatory affairs and quality systems.
Working with international clients across US FDA, EU MDR, Health Canada, and CDSCO, this role offers hands-on exposure to real-world regulatory documentation, audits, and compliance activities under expert mentorship.
Key Responsibilities – RA/QA Medical Device Jobs
- Assist in preparation and compilation of US FDA 510(k), EU MDR Technical Files, Health Canada, and CDSCO submissions
- Support development and maintenance of Design History File (DHF), GSPR checklists, and Technical Documentation
- Contribute to risk management activities (FMEA, hazard analysis) as per ISO 14971
- Assist in verification & validation (V&V) documentation
- Support Clinical Evaluation Reports (CERs), PMS reports, and PSURs
- Help create and update SOPs, templates, and work instructions
- Ensure compliance with ISO 13485:2016 Quality Management Systems
- Support internal and external regulatory and quality audits
- Collaborate with cross-functional teams and senior RA/QA consultants
- Participate in ongoing training and continuous learning initiatives
Eligibility & Qualifications
- Bachelor’s or Master’s degree in:
- Biomedical Engineering
- Medical Electronics
- Biotechnology
(AICTE / UGC recognized institutions only)
- Freshers or candidates with up to 6 months of experience can apply
- Electronics & Instrumentation or Mechanical Engineers with medical device exposure may be considered
- Strong written and verbal English communication skills
- Basic understanding of medical device lifecycle and regulatory principles
- Willingness to learn US FDA, EU MDR, ISO 13485, ISO 14971, IEC 60601, IEC 62304
- High attention to detail, documentation accuracy, and professionalism
Why Join ELEXES Medical Consulting?
- Hands-on experience with global medical device regulatory projects
- Exposure to international regulatory standards and submissions
- Strong mentorship from experienced RA/QA professionals
- Flexible Work-From-Home (WFH) options
- Competitive entry-level compensation and long-term career growth in medical devices
Salary Package (Expected)
- ₹3,00,000 – ₹5,00,000 per annum (CTC)
(Based on qualifications, skills, and interview performance)
How to Apply
Eligible candidates can apply by sending their updated resume to:
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📧 lisa@elexes.com
📧 hr@elexes.com
📌 Mention “Project Associate I – RA/QA” in the email subject line.
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