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.
Numbers & Facts
| Location | North Haven, CT |
| Industry | Staffing/Employment Agencies |
| Salary | $45 |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.
Skills
- Adobe FrameMakerunmatched
- Adobe InDesignunmatched
- Communication Skillsunmatched
- Cost Estimatesunmatched
- Cross-Functionalunmatched
- Data Collectionunmatched
- Delivery Managementunmatched
- Documentationunmatched
- Engineering Change Managementunmatched
- Engineering Change Orderunmatched
- Illustrating Abilityunmatched
- Interviewing Skillsunmatched
- Medical Equipmentunmatched
- Medical Writingunmatched
- Presentation/Verbal Skillsunmatched
- Product Requirements Document (PRD)unmatched
- Product/Service Launchunmatched
- Quality Managementunmatched
- Regulationsunmatched
- Regulatory Submissionsunmatched
- Technical Writingunmatched
- Writing Skillsunmatched
- XML Toolsunmatched
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