Abbott is a global healthcare leader dedicated to helping people live healthier lives. With a portfolio spanning diagnostics, medical devices, nutrition, and branded generic pharmaceuticals, Abbott operates in over 160 countries. The company is committed to innovation, quality, and compliance, ensuring that its medical devices meet the highest regulatory standards worldwide.
Job Description
Abbott is seeking a Regulatory Affairs Specialist for its Medical Devices division in New Delhi. The ideal candidate will ensure compliance with CDSCO (Indian Medical Device Rules 2017), US FDA, CE Marking, and other global regulations. This role involves preparing regulatory submissions, maintaining compliance, and supporting product development teams.
Key Responsibilities:
✔ Prepare and submit regulatory dossiers for CDSCO, US FDA, CE Marking, and other international markets.
✔ Ensure compliance with India’s Medical Device Rules (IMDR 2017) and amendments.
✔ Liaise with CDSCO, notified bodies, and global regulatory agencies for approvals and audits.
✔ Monitor changes in medical device regulations and update internal teams.
✔ Provide regulatory guidance during product development, clinical trials, and post-market surveillance.
✔ Maintain regulatory documentation and tracking systems.
✔ Support internal/external audits and inspections.
✔ Collaborate with R&D, Quality Assurance, and Marketing teams.
Qualifications & Skills:
✅ Bachelor’s/Master’s in Pharmacy, Biomedical Engineering, or Life Sciences.
✅ 3–6 years of experience in regulatory affairs (medical devices/pharma).
✅ Strong knowledge of CDSCO, US FDA, CE Marking, ISO 13485.
✅ Experience in regulatory submissions and product lifecycle management.
✅ Excellent communication, documentation, and project management skills.
Preferred Skills:
✔ Experience with India, Pakistan, Sri Lanka, Bangladesh regulatory submissions.
✔ Familiarity with regulatory software & document management systems.
