Posted:2 weeks ago|
Platform:
Work from Office
Full Time
Role & responsibilities Proficient knowledge of EU regulations (MDR/MDD), US regulations and regulations outside of the EU. Demonstrated strong 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
Lupin
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