Job Title: Regulatory Affairs Specialist – Medical Devices
Location: New Delhi, India
Department: Regulatory Affairs
Experience Required: 3–6 years
Reports To: Regulatory Affairs Manager
Job Summary
Join a leading healthcare and medical devices company as a Regulatory Affairs Specialist based in New Delhi. In this role, you will be responsible for regulatory compliance, dossier preparation, and product registrations aligned with Indian and international medical device regulations. You will collaborate across product development, clinical, and quality teams to support regulatory strategy and global market access.
Key Responsibilities
Prepare and submit regulatory dossiers for product registrations, renewals, and variations to CDSCO and global authorities.
Ensure compliance with Indian Medical Device Rules (IMDR) 2017 and other international regulatory frameworks.
Interface with regulatory bodies, notified bodies, and government agencies for inspections and approvals.
Track and interpret regulatory changes and communicate updates to internal teams.
Provide regulatory guidance during product development, clinical trials, and post-market surveillance.
Maintain accurate regulatory records and support audit readiness.
Collaborate with cross-functional departments including R&D, QA, and Marketing.
Required Skills & Qualifications
Bachelor’s or Master’s degree in Pharmacy, Biomedical Engineering, Life Sciences, or equivalent.
3–6 years of regulatory affairs experience in the medical device or pharmaceutical industry.
Strong understanding of CDSCO, CE marking, US FDA regulations, and ISO 13485 compliance.
Experience in preparing regulatory submissions and managing product lifecycle documentation.
Proficiency in regulatory software tools and document control systems.
Excellent communication, analytical, and documentation skills.
Preferred Skills
Experience with regulatory submissions in India, Sri Lanka, Pakistan, and Bangladesh.
Familiarity with global market approvals and regulatory audits.
Perks & Benefits
Competitive compensation based on experience
Professional growth in a regulated, high-impact healthcare domain
Opportunity to work with a cross-border, collaborative team
Exposure to global regulatory environments and evolving device standards
Health benefits and continuous learning support
Company Description
Join a global healthcare and medical devices leader focused on regulatory excellence, innovation, and patient safety. With a strong presence in South Asia and beyond, the organization drives compliance and quality across the product lifecycle, supporting better patient outcomes worldwide.
Work Mode: On-site (New Delhi, India)
Call to Action
If you're a detail-oriented regulatory professional ready to impact device approvals and global compliance, apply now to become part of a leading medical device regulatory team in India.
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