About Us

Remagine Labs is a MedTech startup developing wearable electro-pharmaceutical drug delivery devices for chronic conditions, including epilepsy. Our patch combines a hydrogel drug reservoir, integrated electronics and controlled iontophoretic delivery. We are backed by a licence and development partnership with a global biopharmaceutical company. Our first clinical manufacturing campaign and Phase 1 study are ahead of us.

About the Role

Take our quality management system from early implementation to clinical-stage readiness, and own it from there. Our electronic QMS platform is selected and initial configuration is underway. You will assess what is in place, complete the build, author the procedures, and get us audit-ready across both the device and drug sides of a combination product. This is a hands-on role reporting to the CEO.

We are open on level. You may set quality strategy and execute it outright, or run the system day to day with strategy and regulatory interpretation from our retained quality consultant. Tell us in your application which of these you are and we will scope the role, title and package accordingly.

Key Responsibilities

- Complete configuration and validation of our electronic QMS, and establish document, change and training control that sticks across the team

- Author the core procedures: document control, change control, CAPA, deviations, supplier quality

- Own the quality framework across device and drug elements, aligned to ISO 13485, FDA QMSR and cGMP

- Maintain design controls and the design history file through design freeze

- Establish GMP documentation for the drug product: master batch records, specifications, batch review and release

- Support qualification of the clinical manufacturing suite and give quality oversight of the Phase 1 campaign

- Qualify suppliers and contract manufacturers, and own the quality agreements