Senior Technical Writer
Entegee · North Haven, Connecticut, United States
FULL TIMEpermanent
Job Description
12+ Months Contract with a potential to go DirectHybrid
Qualifications, skills, and all relevant experience needed for this role can be found in the full description below.
OverviewDevelop and update medical device labeling and Instructions for Use (IFUs) to meet regulatory and quality requirements.
ResponsibilitiesWrite and update IFUs based on cross-functional feedback and applicable standards.Manage labeling approvals, Engineering Change Orders, translations, and product launch distribution.Review labeling proofs and support regulatory submissions, CAPAs, and audits.Collaborate with cross-functional teams to complete labeling deliverables.
RequirementsBachelor’s degree with relevant experience.Medical device labeling and CAPA experience.Experience with InDesign, FrameMaker, XML tools, or similar authoring tools. xzbcwsv Experience in regulated environments with established quality processes.
Qualifications, skills, and all relevant experience needed for this role can be found in the full description below.
OverviewDevelop and update medical device labeling and Instructions for Use (IFUs) to meet regulatory and quality requirements.
ResponsibilitiesWrite and update IFUs based on cross-functional feedback and applicable standards.Manage labeling approvals, Engineering Change Orders, translations, and product launch distribution.Review labeling proofs and support regulatory submissions, CAPAs, and audits.Collaborate with cross-functional teams to complete labeling deliverables.
RequirementsBachelor’s degree with relevant experience.Medical device labeling and CAPA experience.Experience with InDesign, FrameMaker, XML tools, or similar authoring tools. xzbcwsv Experience in regulated environments with established quality processes.
Details
| Company | Entegee |
| Location | North Haven, Connecticut, United States |
| Type | FULL TIME |
| Niche | hr |
| Experience | permanent |