Technical Writer
Skills
ActingClinical ResearchTrainingDocument CreationFSPMedical DevicesRegulatory Requirements
What the job involves
The main requirements, responsibilities and hiring steps.
Requirements
- BA BS or BSN required
- Advanced degree preferred
- Experience in the medical device industry
- Knowledge of CER regulatory requirements
- Experience with evidence generation and CER document creation
- Strong verbal communication skills
- Strong interpersonal relationship skills
- Knowledge of clinical research
- Knowledge of quality regulatory compliance
- Knowledge of adverse event reporting
- Knowledge of medical device risk management process
- Knowledge of common statistical methods preferred
Nice to have
- Detail-oriented
- Collaborative
- Compliance-focused
- Process-minded
- Mentoring ability
Day to day
- Plans and writes Clinical Evaluation Reports and Summary of Safety and Clinical Performance Reports for a medical device client.
- Conducts technical reviews to ensure document accuracy, regulatory compliance, and adherence to local procedures and guidelines.
- Partners with team members, manages daily priorities, and helps improve process efficiency through workshops and continuous education.
- Supports audits and inspections and may serve as a subject matter authority on related processes and reports.