Long Description Key Responsibilities Proficient knowledge of EU regulations MDR MDD US regulations and regulations outside of the EU Demonstrated robust writing and communication skills Conduct proofreading editing document formatting review comment integration and document completion approval activities Strong concise scientific style of writing with a high level of attention to detail Perform Design control documentation activities in accordance with ISO 13485 21 CFR part 820 EU MDR Prepare and Review technical documentation for regulatory submission in US EU market Work Closely with regulatory quality manufacturing Clinical teams for preparation of technical documentation Stay updated on relevant standards and industry best practices including ISO 10993 ISO 11608 ISO 14971 IEC 62366 etc Define product specifications Conduct Risk assessments and contribute to design failure mode effect analysis dFMEA to proactively address potential risks and improve device safety and performance Competencies Education Masters in Pharmaceutical Technology or Microbiology Graduation Work Experience 5 years of experience in writing technical documentation for different market Knowledge of relavant regulatory framework and standards including ISO 13485 21 CFR part 820 EU MDR and other applicable standards Excellent communication and documentation skill

📌 Associate Scientist (Pune)
🏢 LUPIN
📍 Pune