Technical Writer Medical Devices and Combination Products
Core
Producing compliant design control documentation for high-risk Class III medical devices and combination products throughout the R&D lifecycle.
Role type
Senior Technical Writer (Medical Device Design Controls)
Builds
Design History File (DHF) documentation, clinical/biological evaluation reports, regulatory submission packages, and Instructions for Use (IFUs).
Domain
Medical Devices / Combination Products / Regulatory Affairs
Required skills
Design controls lifecycle management, risk management (ISO 14971), verification and validation (V&V) documentation, clinical evaluation reporting, biological evaluation reporting, regulatory submission preparation, systematic literature review, combination product development knowledge, global medical device regulations (EU MDR, FDA, TGA), technical/scientific writing.
Preferred skills
Experience with implantable devices, experience with human factors documentation, experience with early FDA interactions.
Technologies
ISO 14971, EU MDR, FDA, TGA
Responsibilities
Develop and maintain Design History File (DHF) documentation including design inputs/outputs and V&V protocols; Collaborate with engineering and QA teams to ensure documentation traceability and compliance; Conduct systematic literature reviews to support safety and performance claims; Compile risk management documentation; Contribute to preparation of pre-submission packages and early CMC roadmaps; Develop Instructions for Use (IFUs) and product labeling.
Seniority
Senior, hands-on IC
