OptraSCAN is a global leader in digital pathology solutions, leveraging AI and advanced imaging to revolutionize diagnostic workflows. Our cutting-edge technology enhances accuracy and efficiency in pathology, supporting healthcare professionals worldwide.
Job Title: Technical Writer (Regulatory)
Location: Pune, Maharashtra (On-site)
Job Type: Full-time
Experience: 3-6 years
Key Responsibilities:
✅ Regulatory Documentation & Submissions
- Prepare Technical Files, Design Dossiers, Clinical Evaluation Reports (CERs), Risk Management Files
- Assist in FDA 510(k), EU MDR, and other global submissions
- Collaborate with R&D, QA, and Clinical teams for compliance
✅ Technical Writing
- Develop SOPs, user manuals, IFUs, and labeling
- Simplify complex technical data into clear, compliant documentation
✅ Compliance & Standards
- Ensure adherence to ISO 13485, ISO 14971, IEC 62304, EU MDR, FDA 21 CFR Part 820
- Track regulatory updates and implement necessary changes
✅ Quality System Support
- Maintain audit-ready documentation
- Assist in CAPA and post-market surveillance reports
Eligibility & Qualifications
✔ Education: Bachelor’s/Master’s in Life Sciences, Biomedical Engineering, Pharmacy
✔ Experience: 3-6 years in medical device regulatory writing
✔ Skills:
- Strong knowledge of FDA, EU MDR, ISO standards
- Excellent technical writing & documentation skills
- Familiarity with SaMD (Software as a Medical Device) preferred
✔ Certifications (Preferred): RAPS RAC or similar
Why Join OptraSCAN?
🔹 Innovative Work Environment – Work with AI-driven digital pathology solutions
🔹 Career Growth – Opportunities in regulatory strategy & compliance
🔹 Global Impact – Contribute to life-saving medical technology
🔹 Competitive Salary & Benefits
How to Apply
