Regulatory Postmarket Specialist
4 weeks ago
The Regulatory Postmarket Specialist provides expertise and support for the development of post-market strategies, plans and reports for new and existing Intuitive products. This individual will work with cross-functional teams in the development of post-market strategies and create documentation including the plans and reports (e.g. post-market clinical follow-up plans, periodic safety update reports), which support regulatory approvals and compliance. The role will require close partnership with cross-functional teams including Regulatory Affairs, Post Market Surveillance, Quality Assurance, Risk Management, Medical Science, Clinical Affairs and Medical Affairs.
Essential Job Duties
- Support the development of strategies that meet regulatory post-market requirements in collaboration with cross-functional teams.
- Create regulatory post-market documentation such as PMCF Plans and PSURs.
- Summarize data and use methods of data presentation that improve the quality and readability of reports and documentation.
- Build relationships with key stakeholders and cross-functional partners including Regulatory Affairs, Post Market Surveillance, Quality Assurance, Risk Management, Medical Science, Clinical Affairs and Medical Affairs.
- Apply working knowledge of European Union Medical Device Regulation (MDR) to guide project teams through the regulatory postmarket requirements.
- Demonstrate good judgement for obtaining solutions.
- Work to balance priorities and drive results with some supervision.
- Facilitate effective team collaboration by leading meetings, using software tools (e.g. Zoom, Box, Sharepoint), and developing dashboards and other communication tools.
- Draft and assemble documentation as required for internal records and regulatory submissions.
- File documentation in systems such as Agile.
- Participate in process improvement activities to continuously improve process effectiveness.
- Other tasks and projects may be assigned as necessary.
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