Regulatory Affairs Specialist

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

Essential Experience:

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

Desirable Experience:

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)