Long Description

Key Responsibilities : * Proficient knowledge of EU regulations (MDR/MDD), US regulations and regulations outside of the EU.
Demonstrated solid writing and communication skills
Conduct proofreading, editing, document formatting, review comment integration, and document completion/approval activities
Solid, 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