Technical Writer

Role- Technical Writer

Experience- 6yrs-8 yrs and 8yrs-10yrs

Contract to hire Position in product base company

location- Pune

Interested candidate cans share profile at -:

juhi.srivastava@randstad.in

k.minakshi@randstad.in

Technical Writer,

You have the opportunity to:

Sleep & Respiratory Care (S&RC) Research & Development (R&D) global hardware engineering group as a Technical Writer focused on technical contents including labels for medical devices.

Be part of organization with culture of Impact with Care for patients, people, and planet with patient safety, quality and integrity at the heart You are responsible for:

Works under minimal supervision and review for technical writing duties, processes, and roles outlined below and serves often as a labeling project manager for the products assigned Member of project team for assigned products and provides labeling analysis on the Product Development Plan. Supports labeling activities for sustaining projects, and labeling updates needed due to changes in US or international regulations. Creation, revision, and execution of Labeling Plans for assigned products in the US and international markets. Creation, revision, review, and approval of Labeling (User Manuals, Provider Manuals, Quick Start Guides, Product Labels, Packaging Labels, Help Files, etc.) Partners with Translation Coordinator(s) throughout the execution of the associated Labeling Plans. Interfaces with Business Unit functions as needed to resolve labeling concerns and supports labeling process improvement efforts as needed. Develops and maintains proficiency in US and international regulations and standards, with a focus on Labeling for assigned products and global impact but a regional focus on the US (FDA), EU (MDD), Canada (Health Canada), Brazil, China, Japan, and Australia. To succeed in this role, you should have the following skills and experience:

Experience with page layout, word processing, computer-generated illustrating, and document control with Tools: Adobe Acrobat, Adobe In-Design, Adobe Illustrator, SnagIt, RoboHelp, Microsoft Office,

SAP Bachelors or masters degree in Electronics, Software, Mechanical, Biomedical Engineering More than 3 years of experience in technical documentation for medical device industry Practical experience of medical device content management system Hands-on experience for development and sustenance of medical device and parts labels Expertise in design documentation including requirements specification, label artworks, test plans, test procedures, test records Well versed with New Product Introduction (stage gate process) & Life Cycle Sustenance of medical product Hands-on experience in medical device documentation: DHF, DMR, BOM and Spec release Exposure to International Quality and Regulatory Standards e.g. IEC, FDA, CFR, MDD, UL, CE, CSA, BIS Fluent in verbal and written English, proactive, can-do attitude, team player, decisive and entrepreneurial attitude, strong analytical and problem-solving skills Display perseverance & agility with execution excellence mindset,Support global technical writing team in label creation activities from India for MDD and MDR projects.