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Regulatory Affairs Executive – Regulatory & Safety (Radiology & Imaging Systems)
Looking for rewarding regulatory affairs jobs in the medical device industry? This opportunity as a Regulatory Affairs Executive in the Radiology & Imaging Systems division offers an exciting chance to combine technical expertise with compliance leadership. Ideal for candidates from biomedical engineering jobs backgrounds, this position focuses on documentation, certification, and coordination with key authorities—perfect for professionals aspiring to grow as regulatory affairs specialists in a fast-evolving sector.
About the Company
The Regulatory & Safety – Radiology Division operates at the forefront of healthcare innovation, ensuring medical imaging systems such as X-Ray, C-Arm, Digital Radiography, and CT equipment meet stringent safety and quality standards. Located in Vapi, Gujarat, the team collaborates with national and international bodies including BIS, AERB, and NABL, ensuring full regulatory compliance and technical excellence. This environment provides tremendous growth for those pursuing long-term regulatory affairs jobs or building a career as a regulatory affairs specialist.
Job Overview:
The Regulatory Affairs Executive will oversee and manage regulatory documentation, compliance processes, and certifications for radiology and imaging systems. The role involves maintaining technical files, liaising with regulatory bodies, and ensuring that all manufacturing and testing processes comply with BIS, AERB, NABL, and ISO standards. This is an excellent opportunity for candidates seeking practical exposure in regulatory affairs jobs within the healthcare and biomedical engineering sector.
Qualification Required:
- B.E./B.Tech/Diploma in Electronics or Biomedical Sciences/Engineering.
- 3–5 years of experience in regulatory affairs, documentation, or compliance within a medical device or imaging systems setup.
- Strong knowledge of BIS, AERB, NABL, ISO 13485, GMP, and IEC 60601 standards.
Key responsibilities for regulatory affairs jobs:
- Prepare and maintain regulatory documentation for product approvals under BIS, AERB, and NABL guidelines.
- Coordinate product registration, certification renewals, and compliance updates.
- Collaborate with cross-functional teams to ensure ISO 13485, IEC 60601, and QA testing compliance.
- Liaise with regulatory bodies and testing laboratories for evaluation and audits.
- Maintain documentation databases and ensure traceability, control, and version management.
- Support internal and external audits to ensure inspection readiness.
- Provide training to internal teams on regulatory documentation and updates.
Skills Required for Regulatory Affairs Jobs:
- Excellent understanding of medical device regulatory frameworks.
- Strong attention to detail and documentation accuracy.
- Effective communication and coordination skills with authorities and teams.
- Proficiency in MS Office, ERP, and documentation systems.
- Analytical mindset and ability to interpret technical and compliance guidelines.
If you’re ready to elevate your career in regulatory affairs jobs, this position offers a perfect balance of technical rigor and professional growth. Join a leading healthcare manufacturer, contribute to compliance excellence, and enhance your expertise as a regulatory affairs specialist in the rapidly advancing field of biomedical engineering jobs.
How to Apply:
Interested candidates can apply through the company’s official career portal or send their applications via the HR department’s contact listed in the company website alerts.
