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<p>Join our dynamic team at Haemonetics, where we are on the lookout for dedicated talent. If you are seeking a challenging yet rewarding career in a diverse and vibrant work environment, this is the place for you!</p><p>The Lead Technical Writer will play a crucial role in creating, revising, and maintaining comprehensive end-user documentation for medical devices, ensuring adherence to all regulatory and quality system requirements. The ideal candidate will possess extensive experience in FDA- and ISO-regulated environments and be highly skilled in using MadCap Flare for developing structured, reusable content. This role requires a balance of independence and collaborative effort to guarantee documentation accuracy, regulatory compliance, and uniformity across various product lines.</p><p>As a Lead Technical Writer, you will have the opportunity to:</p><ul><li><p>Oversee large or intricate documentation projects across multiple product lines or areas of specialization.</p></li><li><p>Engage in technically sophisticated and high-impact projects, exercising creativity and an understanding of business principles.</p></li><li><p>Draft, update, and obtain approvals for technical documents while ensuring consistency throughout.</p></li><li><p>Participate in the enhancement of templates, style guides, and publishing workflows to improve efficiency.</p></li><li><p>Contribute to project strategies, managing resources effectively, and assessing potential risks for optimal mitigation.</p></li><li><p>Conduct independent research to address topics beyond existing technical writing expertise, applying effective methods to achieve goals.</p></li><li><p>Recognize and apply medical device industry standards, processes, policies, and regulations, including relevant Standard Operating Procedures (SOPs).</p></li><li><p>Exhibit advanced knowledge of technical writing techniques and theories, translating complex product and customer needs into clear documentation requirements.</p></li><li><p>Analyze data to inform the development and dissemination of technical documentation.</p></li><li><p>Demonstrate exceptional project management capabilities along with proficient systems knowledge and basic business insight.</p></li><li><p>Coordinate work across project teams and related departments.</p></li><li><p>Communicate effectively at all levels, providing regular updates and status reports to management.</p></li><li><p>Employ problem-solving skills to tackle complex issues while assessing the short-term implications of various recommendations.</p></li><li><p>Enhance cultural awareness in communication with diverse audiences.</p></li><li><p>Provide mentorship and technical leadership to junior writers and team members.</p></li><li><p>Resolve complex issues by engaging in collaborative problem-solving strategies.</p></li><li><p>Evaluate the techniques and solutions suggested by junior writers to ensure quality documentation.</p></li><li><p>Undertake additional responsibilities as assigned to meet business needs.</p></li></ul><p><b>Required Qualifications:</b></p><ul><li><p>Bachelor's Degree or higher in English or Technical Writing.</p></li><li><p>At least 5 years of experience as a technical writer within the IVD/Medical Device sector (Life Sciences).</p></li><li><p>Experience working within a Quality Management System (QMS).</p></li><li><p>Strong understanding of structured documentation and version control.</p></li><li><p>Knowledge of medical device industry regulations and governance.</p></li><li><p>Advanced proficiency in MadCap Flare.</p></li><li><p>Exceptional written and verbal communication abilities.</p></li></ul><p><b>Preferred Qualifications:</b></p><ul><li><p>Familiarity with global labeling requirements (FDA, EU MDR, IVDR, Health Canada, etc.).</p></li><li><p>Experience with Adobe Acrobat, Adobe FrameMaker, and graphic design tools.</p></li><li><p>Knowledge of Smartsheet.</p></li></ul><p><b>Core Competencies:</b></p><ul><li><p>Detail-focused with a strong commitment to quality.</p></li><li><p>Ability to manage multiple projects simultaneously.</p></li><li><p>Strong collaborative skills across functions.</p></li><li><p>Awareness of regulatory standards and risk-based thinking.</p></li><li><p>Process-oriented with a results-driven mindset.</p></li><li><p>Able to work independently with minimum supervision.</p></li></ul><p>Haemonetics is an equal opportunity employer. Join us and be a part of a team dedicated to improving lives through innovation and quality in the medical device industry.</p><p>The base salary range for this role is: $90,100.00-$153,300.00/Annual.</p>
