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Contributes to the project strategy to meet target goals and milestones, evaluates resource allocation needs, and monitors project risks to determine the best mitigation path. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms.

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We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice. Job Details The Senior Technical Writer is responsible for authoring, revising, and maintaining end-user documentation for medical devices in compliance with applicable regulatory and quality system requirements. The ideal candidate has demonstrated experience working within FDA- and ISO-regulated environments and is highly proficient in MadCap Flare for structured, reusable content development. This individual operates with moderate independence and partners cross-functionally to ensure documentation accuracy, regulatory compliance, and consistency across product lines. The Senior Technical Writer may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. <ul><li>Performs large or complex portions of documentation projects across multiple product lines or specialization areas. </li><li>Works on technically complex and high-impact projects and deliverables where ingenuity and basic business understanding is required. </li><li>Creates, revises, and seeks approval of documentation and ensures consistency across documentation. </li><li>Contributes to continuous improvement of templates, style guides, and publishing workflows. </li><li>Contributes to the project strategy to meet target goals and milestones, evaluates resource allocation needs, and monitors project risks to determine the best mitigation path. </li><li>Independently research issues outside of current technical writing knowledge and capability and selects the most efficient methods/techniques to achieve objectives. </li><li>Identifies technical writing and medical device industry standards, processes, policies, practices, and tools including Standard Operating Procedures (SOP)s, industry best practices, style guides, templates, desktop publishing tools, and applicable regulations (Examples: FDA, CE Marking, and ISO). </li><li>Applies knowledge to a variety of assignments reflecting proficiency in a broad range of complex topics. </li><li>Demonstrates deep/advanced knowledge of technical writing theory and methods. </li><li>Translates specialized product needs, customer needs, operational policies and processes, and product use into feasible documentation requirements and recommendations. </li><li>Researches and analyzes data relating to the development and distribution of technical documentation. </li><li>Demonstrates advanced project management skills, systems knowledge/skills, and basic business understanding. </li><li>Coordinates work primarily across project team(s), related groups, or within the department. </li><li>Communicates proactively and effectively at all levels. Provides frequent status reports and updates to manager. </li><li>Independently solves a wide range of complex and diverse problems and evaluates and communicates short term impact of recommendations. </li><li>Expands understanding and employs sensitivity in communications with culturally diverse audiences. </li><li>Provides technical leadership, trains, mentors, and takes initiative to assist junior writers and others. </li><li>Troubleshoots complex problems and engages others in problem-solving strategies to identify practical and effective solutions to complex issues. </li><li>Evaluates the applicability and impact of technical writing methods and solutions referred by junior writers. </li><li>Other duties as assigned </li></ul>Required Qualifications: <ul><li>Bachelor's Degree, or higher in English or Technical Writing </li><li>Minimum 5 years of experience as a technical writer within an IVD/Medical Device Business (Life sciences) </li><li>Experience working within a Quality Management System (QMS). </li><li>Strong understanding of structured documentation and version control. </li><li>Experience in medical device industry, regulations and governance requirements </li><li>Advanced proficiency in MadCap Flare </li><li>Strong written and verbal communication skills. </li></ul>Preferred Qualifications:<ul><li>Familiarity with global labeling requirements (FDA, EU MDR, IVDR, Health Canada, etc). </li><li>Experience with Adobe Acrobat, Adobe FrameMaker, and graphics tools </li><li>Knowledge of Smartsheet </li></ul>Core Competencies <ul><li>Detail-oriented with strong quality focus </li><li>Ability to manage multiple concurrent projects </li><li>Strong cross-functional collaboration skills </li><li>Regulatory awareness and risk-based thinking </li><li>Process-oriented mindset </li><li>Ability to work independently with minimal supervision </li></ul>EEO Policy Statement Pay Transparency: The base pay actually offered to the successful candidate will take into account, without limitation, the candidate's location, education, job-knowledge, skills, and experience in prior relevant roles. Incentives may also be provided as part of Haemonetics' employee compensation. For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company's long-term incentive plan, with eligibility and target amount dependent on the role. In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, "flexible time off" for salaried employees and, for hourly employees, accrual of three to five weeks' vacation annually (based on tenure), accrual of up to 64 hours (annually) of paid sick time, paid and/or floating holidays, parental leave, short- and long-term disability insurance, tuition reimbursement, and/or health and welfare benefits. Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting. If you believe you may be entitled to such information by law, you may contact 1-781-348-7777, Monday through Friday, 7:30 a.m. - 5 p.m. ET or email AskHR@Haemonetics.com. The base salary range for this role is: $90,100.00-$153,300.00/Annual

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Senior Technical Writer Haemonetics

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