ELEXES Medical Consulting Pvt Ltd is expanding its Regulatory Affairs & Quality Assurance team and is looking for a motivated Project Associate – I (RA/QA). This role offers hands-on exposure to global medical device regulatory submissions and collaboration with experienced regulatory consultants across international markets.
📍 Location: India
🧑💼 Experience: 1–3 Years
📝 About the Role
As a Project Associate – I (RA/QA), you will support regulatory submissions, technical documentation, and quality assurance activities for medical devices and software products. You’ll work closely with cross-functional teams to deliver compliant, high-quality regulatory documentation on time.
📊 Key Responsibilities
- Author and compile regulatory submissions for global markets:
- US FDA 510(k)
- EU MDR Technical Documentation
- Health Canada submissions
- CDSCO submissions
- Draft and review product & software documentation, including:
- Design History Files (DHF)
- GSPR checklists
- EU MDR Technical Files
- Prepare design control documentation, including:
- Verification & Validation (V&V) protocols
- Risk management files
- Testing and assessment reports
- Support post-market documentation, such as:
- Clinical Evaluation Reports (CER)
- Post-Market Surveillance (PMS)
- Periodic Safety Update Reports (PSUR)
- Assist in developing and maintaining standard operating procedures (SOPs), templates, and work instructions
📚 Eligibility Criteria
- Bachelor’s or Master’s degree in Biomedical Engineering or a related discipline
- 1–3 years of experience in Regulatory Affairs / Quality Assurance
- Strong English written and verbal communication skills
- Experience in RA activities with exposure to product and clinical documentation
- Understanding of medical device development lifecycle and regulatory expectations
💼 Desired Skills
- Ability to communicate complex technical concepts clearly to international clients and teams
- Strong organizational skills with high attention to detail
- Willingness to learn and grow beyond academic exposure
- Working knowledge of:
- US FDA regulations
- EU MDR
- ISO 13485
- ISO 14971
- IEC 60601
- IEC 62304
🤝 Why Join ELEXES?
- Exposure to global regulatory projects
- Work alongside senior RA/QA consultants
- Challenging and rewarding learning environment
- Strong career growth opportunities in Regulatory Affairs & Quality Assurance
📧 How to Apply
📩 Send your updated resume to lisa@elexes.com
