Core Responsibilities
- Documentation and Dossier Preparation: Assist in drafting and maintaining technical files such as Device Master Files (DMF) and technical dossiers for submission to agencies like the FDA (US), CE (EU), and CDSCO (India).
- Compliance Monitoring: Ensure all manufacturing processes and finished products adhere to international standards, specifically ISO 13485 (Quality Management Systems for medical devices).
- Product Registration: Support the lifecycle management of products by assisting in new product registrations, license renewals, and maintaining global registration databases.
- Labeling and Packaging Review: Review product labels, Instructions for Use (IFU), and promotional materials to ensure they meet legal requirements and accurately reflect product claims.
- Liaison with Authorities: Act as a point of contact for regulatory inquiries, assisting senior executives in responding to queries from government bodies or external auditors.
- Audit Support: Help prepare for internal and third-party audits by ensuring all regulatory files are organized and audit-ready.
- Post-Market Surveillance (PMS): Assist in monitoring product performance after launch, managing safety reports, and handling potential product recalls or field safety corrective actions.
Key Skills and Qualifications
- Education: Usually requires a degree in Pharmacy, Life Sciences, Microbiology, or Engineering.
- Regulatory Knowledge: Basic understanding of frameworks like EU MDR, US FDA 21 CFR Part 820, and ISO 14971 (Risk Management).
- Attention to Detail: Critical for reviewing scientific data and legal documents where minor errors can lead to submission rejection.
- Technical Writing: Ability to clearly present complex scientific data in a concise, structured format for dossiers.
- Communication: Strong interpersonal skills to collaborate with cross-functional teams like R&D, Quality Assurance, and Marketing
Please note that applicants for this position should be from the following locations: Patan, Unjha, and Mehsana.
Pay: ₹15,000.00 - ₹20,000.00 per month
Work Location: In person
