Siora Surgicals, a leading name in the medical devices industry, is hiring a Regulatory Affairs Executive to ensure compliance with global regulatory standards. If you have experience in 510(k), CE Marking, EU MDR, US FDA, and Indian MDR, this is a great opportunity!
Key Responsibilities:
✔ Regulatory Submissions: Handling 510(k), CE Marking, EU MDR 2017/745, US FDA, Indian MDR 2017
✔ Clinical Evaluation Reports (CER): Development, Literature Reviews, Clinical Data Analysis
✔ Risk Management: Knowledge of ISO 14971, Risk Assessments, Mitigation Strategies
✔ Post Market Surveillance (PMS): Data Collection, Reporting, Device Performance Monitoring
✔ Post Market Clinical Follow-up (PMCF): Study Design, Data Analysis, Reporting
About Siora Surgicals
Siora Surgicals is a trusted name in medical devices and surgical equipment, specializing in orthopedic implants and trauma solutions. With a strong presence in India and global markets, the company is known for innovation, compliance, and quality assurance.
How to Apply?
Interested candidates can email their resume to hr@siora.net. Ensure your resume highlights relevant experience in regulatory affairs for medical devices.
Why Join Siora Surgicals?
✅ Work with a globally recognized medical devices company
✅ Competitive salary & growth opportunities
✅ Be part of a dynamic regulatory and quality assurance team