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Engineering - Technical Writer - Exempt
Job Description
Join our team and contribute to the development of cutting-edge medical device labeling. This role is based in North Haven, CT, a vibrant location offering a balance of onsite collaboration and remote work flexibility.
Key Responsibilities
- Plan, research, develop, and write medical device labeling, managing deliverables as part of cross-functional project teams under general supervision.
- Simultaneously manage up to two labeling updates and one small, new-product-introduction project involving multiple labeling pieces.
- Understand and adhere to all quality management system documents and product commercialization procedures applicable to labeling development.
- Conduct interviews with various users and technical staff to gather data for documentation.
- Recommend formats responsive to technical and customer requirements.
- Assist in providing documentation for CAPAs, and departmental and business-unit audits.
- Contribute to time and cost estimates for labeling deliverables for project teams.
- Develop illustrations in cooperation with professional illustrators.
- Participate in department and business-unit initiatives.
- Oversee the Engineering Change Order process for labeling.
- Coordinate translations and track the status of translations.
- Complete labeling proofs, develop documentation for regulatory submissions, and carry out other tasks as assigned.
- Strong collaboration, verbal/written communication skills, and technical writing core competencies.
- Experience with various authoring tools (e.G., InDesign, Framemaker, XML tools).
- Experience in complex regulatory environments and robust quality processes.
- Requires a University Degree and a minimum of 5 years of relevant experience, or an advanced degree with 2 years of experience.
This role requires being onsite 4 days a week, with 1 day remote. Candidates should be located within a reasonable commuting distance to North Haven, CT, as onsite requirements cannot be changed. We are looking to hire and start as soon as possible.
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Staffing Leader of the Year Anju Abel
CEO, LanceSoft
LanceSoft is proud to announce that its Chief Executive Officer, Anju Abel, has been honored with the prestigious "Staffing Leader of the Year" award at the 2025 TIARA Staffing Awards US. The award recognizes her visionary leadership and significant contributions to improving staffing processes, employee engagement, and workforce outcomes.
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The judging panel highlighted Anju's ability to consistently deliver outstanding client success stories, exceed expectations, and foster professional development within her team. Her active community involvement and dedication to advancing the staffing industry were also key factors in her selection.
TIARA Awards are known for celebrating excellence, innovation, and achievement in the talent acquisition sector, and this accolade places Anju among the top leaders reshaping the future of workforce solutions.