Looking for a Regulatory Analyst – Clinical Affairs job in Bengaluru with hands-on exposure to CDSCO and EU MDR clinical documentation? Remidio is hiring experienced professionals with 2–3 years of regulatory medical writing expertise to support global ophthalmic device submissions.
This opportunity is ideal for candidates with experience in Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), and Post-Market Surveillance (PMS) reports, particularly within the medical device or pharma regulatory space.
Remidio is a global leader in AI-powered ophthalmic equipment. The company has achieved:
- CDSCO approval for adaptive ophthalmic AI
- CE Marking under EU-MDR
- FDA registration for ophthalmic devices
- Screening of 16+ million patients across 40+ countries
Remidio focuses on early detection of diabetic retinopathy, glaucoma, AMD, and is expanding toward systemic disease screening such as CVD and CKD.
Job Details
- Position: Regulatory Analyst – Clinical Affairs
- Location: Bengaluru, Karnataka
- Experience: 2–3 Years
- Industry: Medical Devices / Clinical Regulatory Affairs
- Employment Type: Full-Time
Key Responsibilities
The Regulatory Analyst – Clinical Affairs will:
- Collaborate with cross-functional teams to collect and analyze clinical data for regulatory submissions
- Draft and review Clinical Evaluation Plans (CEP)
- Prepare Clinical Evaluation Reports (CER)
- Develop Post-Market Surveillance (PMS) Reports
- Ensure compliance with CDSCO regulations and EU MDR requirements
- Conduct literature searches via PubMed, Cochrane, and similar databases
- Support regulatory audits and inspections
- Monitor updates in medical device regulatory frameworks
This role demands strong expertise in clinical regulatory writing, particularly within the EU MDR and Indian regulatory environment.
Eligibility Criteria
Educational Qualification:
- Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Biomedical Sciences, or related field
- Advanced degree preferred
Experience Required:
- 2–3 years of experience in regulatory medical writing
- Experience in medical device clinical documentation preferred
- Hands-on exposure to CDSCO and EU MDR clinical evaluation processes
Technical Skills:
- Strong understanding of medical device regulatory frameworks
- Expertise in literature search (PubMed, Cochrane)
- Knowledge of clinical evaluation and post-market surveillance documentation
Soft Skills:
- Excellent scientific writing skills
- Detail-oriented and deadline-driven
- Strong communication and stakeholder coordination ability
Salary & Benefits (Estimated)
- Expected Salary Range: ₹6,00,000 – ₹9,00,000 per annum (based on experience)
- Exposure to global regulatory frameworks (EU MDR, CDSCO)
- Work with AI-driven healthcare innovation
- Fast-paced, technology-focused environment
- Career growth in medical device regulatory affairs
Why This Role is Important
With increasing regulatory scrutiny under EU MDR and expanding Indian regulatory oversight, the demand for skilled Regulatory Analysts in Clinical Affairs is rising. This opportunity at Remidio offers practical exposure to global submissions and clinical documentation strategy—valuable for professionals aiming to grow in medical device regulatory affairs careers in India.
How to Apply
