Job Description

Key Responsibilities

Regulatory Strategy: Monitor changes in India's Medical Device Rules & global standards (MDR/IVDR, USFDA) impacting products. Submissions: Prepare, compile, and file regulatory documents for new product approvals and renewals with the Central Drugs Standard Control Organisation (CDSCO). Compliance: Ensure all products, labelling, and processes meet statutory & regulatory requirements (e.g., quality, safety). Documentation: Create clear, user-friendly product information leaflets (PILs), labels, and technical files (e.g., Clinical Evaluation Reports - CERs). Liaison: Act as the main contact for regulatory authorities, consultants, and auditors. Cross-Functional Support: Collaborate with R&D, Quality, Marketing, and Sales teams to provide regulatory guidance throughout the product lifecycle. Post-Market Surveillance: Handle complaints, vigilance reporting, and maintain compliance for marketed devices. Framing SOPs that covers complete product life cycle including the supply chain.

Essential Skills & Qualifications

Candidate should be B.Pharm/M.Pharm or a relevant Science background Strong understanding of medical device regulations (India, EU, US). Excellent written and verbal communication skills. Knowledge of Medical Device Software (SaMD) regulations is a plus. Familiarity with product lifecycle management for devices. Attention to detail and strong organizational skills. Experience: 6 to 8 years' experience in the relevant field. Soft Skills: MS office, Word Excel, PPT, and other applications
Job Type: Full-time

Pay: ?50,000.00 - ?70,000.00 per month

Work Location: In person