Project Associate I – Regulatory Affairs & QA | ELEXES | Freshers

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:

📧 lisa@elexes.com

Tip: Mention “Project Associate I – RA/QA” in the email subject line for faster processing.