BPharma Jobs in Regulatory Affairs
Job Title: Regulatory Affairs Specialist
Company name: RYMO
Location: Navi Mumbai, India (On-site)
Experience: 2–5 years
Reports to: QA In-charge
Salary Range: ₹3.5 – 4.5 LPA
About Rymo
Rymo Technology is developing intelligent robotic rehabilitation systems that transform physical therapy through data-driven insights, automation, and clinical precision. Our mission is to make rehab smarter, faster, and accessible at scale.
Role Overview
As a Regulatory Affairs Specialist at Rymo Technologies, you will be responsible for guiding our innovative physical therapy and rehabilitation devices through medical device regulations. You will manage end-to-end regulatory submissions, ensure compliance with national and international standards, and maintain essential documentation for approvals and certifications.
Key Responsibilities
• Manage regulatory submissions (CDSCO, FDA, CE etc.) and maintain documentation including Device Master Files, Risk Management, and Clinical Evaluation Reports.
• Ensure compliance with ISO 13485, ISO 14971, and relevant IEC standards across the product lifecycle.
• Track post-market requirements, including incident reporting, vigilance activities, and license renewals.
• Design and oversee quality systems, conduct internal and supplier audits, and support regulatory inspections.
• Monitor compliance across departments, manage CAPA processes, and drive continuous process improvements.
• Maintain robust documentation, traceability, and record-keeping throughout development and manufacturing.
Required Qualifications
• Bachelor’s degree in Biomedical, Pharmacy, Regulatory Affairs, or related fields.
• 2–5 years in regulatory affairs (medical devices, health-tech, or diagnostics).
• Strong knowledge of Indian medical device regulations (CDSCO); exposure to EU MDR is a plus.
• Experience preparing technical files and regulatory submissions.
• Excellent documentation, attention to detail, and cross-functional communication skills.
Preferred Qualifications
• Exposure to robotic or electro-mechanical medical systems.
• Certification in Regulatory Affairs or Quality Management (ISO 13485 Lead Auditor, RAC, Six Sigma, etc.) is an advantage.
• Familiarity with IEC 60601, IEC 62304, or ISO 14971 standards.
• Experience with CE marking or international regulatory frameworks.
Why Join Rymo
• Work on impactful technologies improving patient recovery and mobility.
• Be part of a mission-driven and fast-scaling MedTech startup.
• Opportunity to shape regulatory practices and grow into a leadership role.
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