Regulatory Affairs Specialist – Medical Devices (New Delhi)
Job Summary:
We are hiring a Regulatory Affairs Specialist to join a dynamic medical device regulatory team in New Delhi. The ideal candidate will have 3–6 years of experience in regulatory affairs within the medical device or pharmaceutical industry and will support product registrations and regulatory compliance efforts. This role is key in ensuring adherence to CDSCO, CE, US FDA, and ISO 13485 requirements while providing strategic regulatory input throughout the product lifecycle.
Key Responsibilities:
Prepare, compile, and submit regulatory dossiers for product registrations, renewals, and amendments to CDSCO and other authorities.
Ensure adherence to Indian Medical Device Rules (IMDR) 2017 and global regulatory standards.
Liaise with CDSCO, notified bodies, and global agencies for audits and approvals.
Track and communicate changes in regulatory requirements to internal stakeholders.
Provide regulatory guidance for product development, clinical trials, and post-market surveillance.
Maintain up-to-date regulatory documentation and tracking systems.
Support audits and inspections by internal and external parties.
Collaborate with R&D, QA, Marketing, and other cross-functional teams.
Required Skills & Qualifications:
Bachelor’s or Master’s degree in Pharmacy, Biomedical Engineering, Life Sciences, or equivalent.
3–6 years of experience in regulatory affairs for medical devices or pharmaceuticals.
Strong understanding of CDSCO, CE marking, US FDA regulations, and ISO 13485.
Experience in regulatory submissions and lifecycle management.
Excellent written and verbal communication skills.
Preferred Skills:
Familiarity with regulatory procedures in India, Pakistan, Sri Lanka, and Bangladesh.
Proficiency in regulatory software tools and document management systems.
Perks & Benefits:
Competitive salary based on experience
Opportunity to work with global regulatory teams
Professional development and cross-functional collaboration
Exposure to international regulatory frameworks
Company Description:
A leading healthcare and medical device organization committed to innovation and regulatory excellence. The company is dedicated to delivering safe and effective medical technologies aligned with global standards and compliance requirements.
Work Mode: On-site (New Delhi, India)
Call-to-Action:
Ready to elevate your regulatory career in the medical device industry? Apply now and join a high-impact team shaping healthcare compliance across global markets.
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