Ivd Regulatory Writer
2 weeks ago
Cyient is a global engineering and technology solutions company. As a Design, Build, and Maintain partner for leading organizations worldwide, we take solution ownership across the value chain to help clients focus on their core, innovate, and stay ahead of the curve. We leverage digital technologies, advanced analytics capabilities, and our domain knowledge and technical expertise, to solve complex business problems.
With over 15,000 employees globally, we partner with clients to operate as part of their extended team in ways that best suit their organization’s culture and requirements. Our industry focus includes aerospace and defence, healthcare, telecommunications, rail transportation, semiconductor, geospatial, industrial, and energy.
**Job Description**:
- Under general supervision, responsible for writing technical copy for various operation and maintenance manuals and technical publications.
- Prepares written text and coordinates layout and organization of manuals and other documents according to prepared outlines and specifications.
- Researches available technical data including drawings, design reports, equipment, and test specifications.
- May work with engineers and other technical personnel to clarify document contents.
- Preparation and writing of Technical Documentation for in vitro diagnostic medical devices in compliance with IVDR and internal procedures.
- Writing the Instruction for Use in accordance with IVDR requirements and internal procedures.
- Ensure product labels meet the IVDR requirements and internal procedures.
- Contribute to risk management activities.
- Review and provide regulatory inputs to critical deliverables for technical documentation (Post-Market Surveillance Plan, Risk management Plan, Risk analysis, Risk management report, Performance evaluation plan and report, Analytical and Clinical performance reports, Design and manufacturing documentation).
- Support the gap analysis of new/updated regulatory guidance related to IVDR.
- Manage the follow up of the registration procedures and preparation of responses to the Notified Body.
Skills & Experience
ISO 13485 Medical Devices, Quality Control, - Clinical/ medical writing /regulatory writing experience - FDA (510K) submissions - Excellent communication skills both written and verbal
Cyient is an Equal Opportunity Employer.
Cyient recruits, employs, trains, compensates, and promotes regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, veteran status, and other protected status as required by applicable law. We are proud to be a diverse and inclusive company where our people can focus their whole self on solving problems that matter.
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