We are looking for innovative candidates to be a key contributor in supporting the development of cutting edge diagnostic methods that will have a direct impact on patient lives. The candidate will support clinical development with primary responsibility for the hands-on management of documentation supporting IVD clinical studies. This candidate will work closely with cross functional development teams to write, edit, review and finalize technical documents required for regulatory submissions of IVD products which includes but not limited to documents for pre-submissions, verification and validation protocols and reports. The secondary role for the candidate is to draft, edit, review and finalize scientific and/or technical documents. The candidate will also review project documentation, assess necessary resources, and estimate timelines for documentation development and review. Knowledge of US and European medical device documentation regulatory requirements would be an advantage. Candidate should have experience with authoring in an agile development environment.
- Coordinating with internal and external experts to organize and maintain documentation pertaining to the life cycle of IVD products.
- Writing, analyzing, and editing user guides, installation guides, and online help systems for future medical devices.
- Collaborates with cross functional team to support successful execution of IVD clinical studies.
- Crafting user-facing documentation based on inputs from cross-functional groups and individuals including, marketing experts, medical experts, regulatory affairs, and product managers.
- Representing the technical writing viewpoint within cross-functional meetings.
- Perform other responsibilities to support the needs of the department as assigned.
- B.S. in a relevant scientific field, such as biochemistry, molecular biology, or cell biology.
- At least 4 years of technical writing experience, preferably in the IVD field and with experience in writing documents for regulatory submissions, such as 510k submissions.
- Experience with drafting, reviewing, editing verification/validation protocols and reports.
- Knowledge of quality and regulatory compliance for IVD product development.