Job Title
Regulatory Affairs Specialist – Medical Devices
Location
New Delhi
Department
Regulatory Affairs
Reports To
Regulatory Affairs Manager
Job Summary
The Regulatory Affairs Specialist will be responsible for ensuring medical devices comply with Indian and international regulatory requirements. The role involves preparing and submitting regulatory documents, maintaining compliance with CDSCO and global authorities, and providing regulatory guidance throughout the product lifecycle, from development to post-market activities.
Key Responsibilities
Prepare, compile, and submit regulatory dossiers for product registrations, renewals, and amendments to CDSCO and other global authorities.
Ensure compliance with Indian Medical Device Rules (IMDR) 2017 and subsequent amendments.
Liaise with regulatory agencies, notified bodies, and other stakeholders for approvals, certifications, and audits.
Monitor changes in regulatory requirements and communicate updates to relevant internal teams.
Provide regulatory input and guidance during product development, clinical trials, and post-market surveillance.
Maintain regulatory documentation, files, and tracking systems.
Support internal and external audits and inspections.
Collaborate with cross-functional teams including R&D, Quality Assurance, and Marketing to ensure regulatory compliance across processes.
Qualifications
Bachelor’s or Master’s degree in Pharmacy, Biomedical Engineering, Life Sciences, or a related field.
3–6 years of experience in regulatory affairs within the medical device or pharmaceutical industry.
Strong knowledge of CDSCO regulations, CE marking, US FDA, and ISO 13485.
Proven experience with regulatory submissions and product lifecycle management.
Excellent communication, documentation, and organizational skills.
Preferred Skills
Experience with regulatory submissions in India, Pakistan, Sri Lanka, and Bangladesh.
Proficiency in regulatory software tools and document management systems.
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