Regulatory Affairs Specialist – Medical Devices

Regulatory Affairs Specialist – Medical Devices

Location: New Delhi
Department: Regulatory Affairs
Reports To: Regulatory Affairs Manager

Job Summary:

The Regulatory Affairs Specialist is responsible for ensuring that medical devices comply with all applicable regulations in India and international markets. This role involves preparing and submitting regulatory documents, maintaining compliance with CDSCO and other global regulatory bodies, and supporting product development teams with regulatory guidance.

Key Responsibilities:

• Prepare, compile, and submit regulatory dossiers for product registrations, renewals, and amendments to CDSCO and other regulatory authorities.

• Ensure compliance with Indian Medical Device Rules (IMDR) 2017 and amendments.

• Liaise with regulatory agencies and notified bodies for approvals and audits.

• Monitor changes in regulatory requirements and communicate updates to internal stakeholders.

• Provide regulatory input during product development, clinical trials, and post-market surveillance.

• Maintain regulatory files and tracking systems.

• Support internal and external audits and inspections.

• Collaborate with cross-functional teams including R&D, Quality Assurance, and Marketing.

Qualifications:

• Bachelor’s or Master’s degree in Pharmacy, Biomedical Engineering, Life Sciences, or related field.

• 3–6 years of experience in regulatory affairs within the medical device or pharmaceutical industry.

• In-depth knowledge of CDSCO regulations, CE marking, US FDA, and ISO 13485.

• Experience with regulatory submissions and product lifecycle management.

• Strong communication and documentation skills.

Preferred Skills:

• Experience with India, Pakistan, Sri Lanka, Bangladesh regulatory submissions.

• Proficiency in regulatory software tools and document management systems.