Regulatory Affairs Specialist

RYMO

5 years

0 Lacs

navi mumbai maharashtra india

Posted:3 days ago| Platform:

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Skills Required

technology rehabilitation data automation regulations compliance documentation certifications healthcare risk management evaluation reporting vigilance design audits support drive traceability development mdr communication certification sigma

Work Mode

On-site

Job Type

Full Time

Job Description

Company Description

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 Description

Regulatory Affairs Specialist

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.

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