Description
- Ensuring the on-time development and delivery of high-quality regulatory documents and MDR for medical devices spanning therapeutic areas
- Engage with internal stakeholders and cross functional client business teams, including Medical Directors, Post-Market Surveillance, Design Quality Engineers, R&D and Regulatory Affairs
- Deliver solutions that are tailored per the clients needs
- Assist the Team Lead in creation of schedules
- Train and mentor junior members of the team on technical and process related aspects
- Proofread, edit, document format and review comment incorporation
- Interpret and present data from device-specific technical documents
- Summarise quantitative data from post-marketing surveillance
- Conduct editing, proofreading, document formatting and other document completion activities