At Phagenesis, we are committed to transforming lives by eliminating the burden of neurogenic dysphagia. As we transform into a high-performing global organization, we’re looking for exceptional individuals who thrive in fast- paced, evolving environments, and bring a strong sense of ownership and urgency to their work.
Our vision is clear—make Phagenyx the standard of care in ICU and acute care settings—and we need ambitious, mission-aligned talent to help us get there. We put patients first, operate with courage and trust, and foster a culture that values innovation, accountability, and a challenger mindset.
Role Overview
This role is responsible for providing guidance on regulatory requirements as well as assisting in regulatory related projects and tasks ensuring compliance with EU, UK and US regulations.
Key Responsibilities
* Preparation of updates to the Technical File
* Support FDA submissions
* Preparation of updates to the Risk Management File
* Maintaining and updating Medical Devices files and Design History Files
* Administration of Applied Standards processes
* Maintenance of Post-market Surveillance processes
* Organization of PMS meetings
* Maintenance of PMS Plans, PSUR, PMCF Plans/ Reports
* Compiling documentation and data for internal and external customers including the Notified Body
* Check, organize and update Regulatory documentation
* Support maintenance of regulatory database registrations
* Liaison with economic operators and management of documentation repositories
Qualifications
* A familiarity with operating to IS013485 and/or QMSR compliant processes & procedures within a medical device company
* A working knowledge of EU, UK and US regulations that affect Class II medical devices
* A Bachelor’s degree with honors or equivalent qualification in a science or engineering discipline
* 3-5 years experience of working within a regulatory department in a medical device company
Skills & Capabilities
* Excellent organizational skills and attention to detail
* Excellent analytical thinking and ability to process and organize data effectively
* A quick learner and self-motivated worker
* Good teamworking capabilities
* IT literate and capable (Excel, Word and database tools)
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