We are seeking a highly motivated Regulatory Compliance Engineer to manage product certifications, regulatory approvals, and compliance activities related to medical and radiology equipment. The candidate will be responsible for ensuring compliance with BIS, AERB, ISO-13485, CDSCO, CE other applicable national and international standards for medical X-ray generators, high-voltage power supplies, and radiology equipment.

Key Responsibilities

Manage certification activities for medical and industrial products.

Coordinate with certification bodies for approvals, registrations, licensing, and compliance requirements related to radiology and X-ray equipment.

Prepare, review, and maintain technical documentation required for regulatory submissions.

Liaise with testing laboratories, certification agencies, and government authorities.

Monitor changes in regulatory requirements and ensure timely implementation.

Conduct compliance gap assessments and risk evaluations.

Support product development teams in meeting regulatory and safety requirements.

Maintain compliance records, test reports, declarations, and certification databases.





Assist in audits, inspections, and regulatory reviews.

Coordinate with customers and OEMs regarding regulatory documentation and approvals.

Ensure compliance with applicable standards related to medical electrical equipment, radiation safety, and quality management systems.

Required Skills

Robust knowledge of certification procedures, Working knowledge of all regulations for medical and industrial X-ray equipment.

Experience in regulatory documentation, technical file preparation, and compliance audits.

Familiarity with ISO 13485, IEC 60601 series, radiation safety standards, and medical equipment certification processes.

Good communication and coordination skills with regulatory authorities and certification bodies.

Ability to manage multiple certification projects simultaneously.

Knowledge on Regulatory/ CDSCO/ CE / Medical Device

Pay: ₹700,000.00 - ₹1,500,000.00 per year

Benefits:

- Health insurance
- Provident Fund

Work Location: In person

📌 Regulatory Compliance Engineer (Dundigal)
🏢 Ionics Power Solutions
📍 Dundigal