Rymo Technology, a leader in robotic rehabilitation systems, is hiring a Regulatory Affairs Specialist in Navi Mumbai, Maharashtra. This role is perfect for professionals passionate about medical device regulations, compliance, and quality management systems. If you have expertise in CDSCO submissions, ISO 13485, EU MDR, and CE marking, this could be your chance to make a meaningful impact in the healthcare technology industry.
🔑 Key Responsibilities
- Manage regulatory submissions (CDSCO, FDA, CE) and prepare technical documentation including Device Master Files, Risk Management, and Clinical Evaluation Reports.
- Ensure compliance with ISO 13485, ISO 14971, and relevant IEC standards throughout the product lifecycle.
- Oversee post-market surveillance: incident reporting, vigilance activities, and license renewals.
- Design and implement quality management systems, conduct internal and supplier audits, and support regulatory inspections.
- Drive CAPA processes, monitor compliance across teams, and enable continuous process improvement.
- Maintain robust traceability, documentation, and regulatory records.
🎓 Required Qualifications
- Bachelor’s degree in Biomedical, Pharmacy, Regulatory Affairs, or related fields.
- 2–5 years of experience in regulatory affairs (medical devices, health-tech, diagnostics).
- Strong understanding of Indian medical device regulations (CDSCO); knowledge of EU MDR is a plus.
- Proven experience preparing regulatory submissions and technical files.
- Excellent documentation, detail orientation, and cross-functional communication skills.
🌟 Preferred Qualifications
- Experience with robotic or electro-mechanical medical systems.
- Certifications in Regulatory Affairs / Quality Management (ISO 13485 Lead Auditor, RAC, Six Sigma).
- Familiarity with IEC 60601, IEC 62304, ISO 14971.
- Exposure to CE marking or global regulatory frameworks.
💼 Benefits
- Work on cutting-edge robotic rehabilitation devices improving patient care.
- Exposure to global regulatory frameworks (India, EU, US).
- Collaborative, innovation-driven work culture.
- Competitive salary and benefits package.
📩 How to Apply
