Medical Device Documentation Specialist
3 days ago
About the Role:
We are seeking a highly skilled Technical Writer to join our team at Planet Pharma. As a Technical Writer, you will be responsible for creating and maintaining high-quality documentation for our medical devices.
Key Responsibilities:
- Develop and maintain technical documentation, including user guides, service manuals, and instructions for use.
- Ensure compliance with regulatory requirements, including FDA and EU Medical Device Regulation.
- Collaborate with cross-functional teams to gather information and develop documentation.
- Manage multiple projects and prioritize tasks to meet deadlines.
- Continuously review and improve the document development process to ensure quality output.
Requirements:
- 2-5 years of experience in technical writing, preferably in the medical device industry.
- Experience with federally regulated environments and EU Medical Device Regulation.
- Excellent writing, editing, and communication skills.
- Ability to manage multiple priorities and work independently.
Nice to Have:
- Experience with Quality/CAPA processes and principles.
- Self-directed and highly organized.
- Product Lifecycle Management software experience.
- Medical terminology experience.
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