Job Description

Long Description
Key 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

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.

Skills Required