Job description

Join our dynamic team in North Haven, CT, a vibrant community known for its rich history and excellent quality of life. We are seeking a dedicated professional to contribute to our Core Surgical/RST Business Units. This role requires being onsite 4 days a week with 1 day remote, offering a great balance of collaboration and 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 on department and business-unit initiatives. • Oversee 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. Required Skills and Experience • 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. • 5-10 years of relevant experience is preferred. Additional Information This position is prioritized for our North Haven, CT location, but we are also open to applicants in Lafayette, CO, and Mounds View, MN. Please ensure your location is noted on the resume, as the commute should be under one hour. We are looking to hire and start candidates as soon as possible.

Requirements

Must-haves

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 on department and business-unit initiatives.
Oversee 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.
Required Skills and Experience
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.
Additional Information

Nice-to-haves

5-10 years of relevant experience is preferred.

Application prep

Use the role’s language and application details while tailoring your materials.

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Benefits detected in the listing.

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