Engineering Technical Writer - Medical Device Labeling

Planet Pharma; North Haven (CT); On-site; USD 70,000 - 110,000; Full time

Job summary

Planet Pharma is seeking a labeling specialist to plan, research, develop, and write medical device labeling and manage labeling deliverables across projects. You will oversee multiple updates, coordinate translations, and ensure compliance with quality systems and regulatory submissions.

This role requires a University Degree and at least 5 years of relevant experience, or an advanced degree with 2 years. You will work with cross-functional teams to meet project milestones and deliverables.

Qualifications

• Requires University Degree with 5+ years of relevant experience, or advanced degree with 2 years.
• Experience in labeling development for medical devices is preferred.
• Ability to work in cross-functional project teams and manage multiple updates.

Responsibilities

• Plan, research, develop, and write medical device labeling and manage labeling deliverables.
• Simultaneously manage up to two labeling updates and one small, new-product-introduction project.
• Understand and adhere to quality management system documents and product commercialization procedures.
• Conduct interviews with users and technical staff to gather data for documentation.
• Recommend formats responsive to technical and customer requirements.
• Assist in providing documentation for CAPAs and audits.
• Contribute to time and cost estimates for labeling deliverables.
• Develop illustrations in cooperation with professional illustrators.
• Oversee Engineering Change Order process for labeling.
• Coordinate translations and track status of translations.
• Complete labeling proofs and develop documentation for regulatory submissions.

Skills

Documentation

Regulatory knowledge

Cross-functional teamwork

Project management

Attention to detail

Education

University Degree

Advanced degree

Job description

Planet Pharma is seeking a labeling specialist to plan, research, develop, and write medical device labeling and manage labeling deliverables across projects. You will oversee multiple updates, coordinate translations, and ensure compliance with quality systems and regulatory submissions.

This role requires a University Degree and at least 5 years of relevant experience, or an advanced degree with 2 years. You will work with cross-functional teams to meet project milestones and deliverables.