Regulatory & Quality Assurance Engineer - Radiology

About the Role

We are seeking a Regulatory & Quality Assurance Engineer specializing in radiology and imaging systems such as X-Ray, C-Arm, Digital Radiography (DR), and CT equipment, located at Vapi, Gujarat. This role is responsible for overseeing and managing regulatory documentation and ensuring compliance with various national and international standards relevant to medical device manufacturing, including BIS, AERB, and NABL.

Key Responsibilities

• Prepare, review, and maintain all regulatory documentation necessary for product approvals and certifications, ensuring alignment with current standards such as BIS, AERB, and NABL.
• Manage technical files, QA test reports, and compliance certificates, coordinating submissions and following up on product registrations, renewals, and amendments.
• Monitor regulatory changes and update internal documents and procedures accordingly.
• Ensure manufacturing, testing, and quality processes comply with ISO 13485, BIS 13450, IEC 60601, ISO 17025, and GMP standards.
• Collaborate across departments including Design, Quality, Production, and Radiation Safety to meet regulatory requirements during product lifecycle stages.
• Support preparations of Technical Construction Files (TCF), Declarations of Conformity (DoC), and other regulatory dossiers.
• Interface with regulatory agencies, certification bodies, and laboratories to coordinate product approvals and compliance verification activities.
• Manage document control processes ensuring traceability, version management, and secure archiving; support internal and external audits and inspections.
• Produce and circulate regular compliance status reports to management.
• Provide guidance and training on regulatory documentation and compliance updates to team members.

Required Qualifications and Experience

• B.E., B.Tech, or Diploma in Electronics or Biomedical Engineering.
• Minimum 3 to 5 years of relevant experience in regulatory affairs, documentation, or compliance within medical device or imaging equipment manufacturing sectors.
• Comprehensive knowledge of BIS, AERB, NABL, ISO 13485, GMP, and IEC 60601 standards.
• Experience handling documentation for X-Ray, C-Arm, DR, and CT systems is highly preferred.

Skills and Competencies

• Deep understanding of regulatory frameworks and documentation protocols for medical devices.
• High accuracy and detailed focus in documentation and data management.
• Effective communication and coordination skills for engaging with regulatory bodies and cross-functional teams.
• Proficiency in MS Office suite, ERP systems, and document control software.
• Strong analytical, organizational skills with the ability to interpret complex technical and regulatory guidelines.

Performance Metrics

• On-time submission and renewal of all regulatory licenses and certifications.
• Full compliance with BIS, AERB, and NABL regulations.
• Maintaining accuracy and completeness of all regulatory documentation.
• Successful audit results marked by minimal observations.
• Efficient collaboration with authorities and testing laboratories.