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ELEXES Medical Consulting Pvt. Ltd. is hiring Project Associate I – Regulatory Affairs & Quality Assurance (RA/QA) to support global medical device regulatory and quality projects. This opportunity is ideal for fresh graduates and early-career professionals looking to build a strong foundation in medical device regulatory affairs and ISO 13485 quality systems.
As a Project Associate I, you will gain hands-on exposure to US FDA, EU MDR, CDSCO, and Health Canada submissions, while working under expert mentorship on real-world medical device projects.
🔍 Key Responsibilities
- Support preparation and compilation of global regulatory submissions (US FDA 510(k), EU MDR Technical Files, Health Canada, CDSCO)
- Develop and maintain Design History Files (DHF), GSPR checklists, and Technical Documentation
- Assist in design controls, risk management activities (FMEA, hazard analysis), and V&V documentation
- Contribute to post-market surveillance deliverables including CER, PMS reports, and PSURs
- Support development and revision of SOPs, templates, and work instructions
- Ensure compliance with ISO 13485:2016 and internal quality management systems
- Assist during regulatory and quality audits
- Collaborate with cross-functional teams and senior RA/QA consultants
- Participate in continuous learning, internal training, and knowledge-sharing initiatives
🎓 Eligibility & Qualifications
- Bachelor’s or Master’s degree in:
- Biomedical Engineering
- Medical Electronics
- Biotechnology
(AICTE / UGC recognized institutions)
- Freshers or candidates with up to 6 months of experience are eligible
- Electronics & Instrumentation or Mechanical Engineering graduates with medical device exposure may apply
- Strong written and verbal English communication skills
- Basic understanding of medical device development lifecycle
- Willingness to learn global standards and regulations:
- 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 international medical device clients
- Exposure to real regulatory submissions and quality documentation
- Strong mentorship from experienced RA/QA professionals
- Opportunity to build a long-term career in medical device regulatory affairs
- Flexible Work From Home (WFH) options
- Competitive salary and professional growth opportunities
📩 How to Apply
Interested candidates should email their updated resume to:
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Tip: Mention “Project Associate I – RA/QA” in the email subject line for faster processing.
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