Senior Medical Device Project Manager

Description:

We are hiring a Senior Medical Device Project Manager to take FeMo from development through clinical studies, regulatory authorisation and manufacturing to launch. You will work closely with the CTO and CEO, our engineering and software teams, and external partners including design houses, regulatory consultants, clinical sites and contract manufacturers. This is a hands-on role: as well as running the plan, you will do a good share of the work yourself.

What you will do

• Own the integrated project plan, budget, risks and timelines across hardware, firmware, app and cloud software

• Coordinate risk management (ISO 14971), software lifecycle (IEC 62304), electrical safety and EMC, biocompatibility, cybersecurity and usability work

• Manage external design, engineering and test suppliers, including scope, cost and delivery

• Plan and track the work needed for the FDA De Novo submission, then EU MDR certification and UK registration

• Work with our regulatory consultants to keep the design and development file and technical documentation complete and submission-ready, and support FDA meetings, inspections and notified body audits

• Manage sponsor obligations for clinical investigations (ISO 14155) and usability studies with sites in the US, Europe and low- and middle-income countries, including site agreements, IRB, ethics, FDA IDE and HPRA submissions, budgets and CRO relationships

• Coordinate the preparation of sections of the design and development file and EU technical documentation for regulatory review

• Run clinical study logistics, including site set-up, device shipments and enrolment tracking

• Liaise with suppliers and the contract manufacturer and manage controlled builds

• Report progress, risks and decisions to the CTO and CEO, and support reporting to the board, investors and grant funders

What you will bring

• Significant project management experience (typically 8 years or more), much of it in medical devices

• Experience on at least one medical device development project that went on to FDA marketing authorisation or CE marking

• Working knowledge of ISO 13485, ISO 14971, FDA QMSR and EU MDR

• Experience managing outsourced partners such as design houses, test labs, CROs or contract manufacturers