Program Manager

We developed neurostimulation as the first line of treatment for pharmacoresistant epilepsy patients. We have partnered with a corporate strategic, received CE Mark under MDR regulations, and launched commercially in EU in 2024.

We are working with the CEO and CTO of Precisis to hire our Program Manager. This position will lead project management and communication for all cross-functional teams. The Program Manager will moderate all activities across regulatory, clinical, and legal requirements

.
The Opportuni

ty
We're looking for a Program Manager, US Market Access to lead one of our most business-critical programs. You will coordinate subprojects across all relevant departments to ensure an on-time commercial launch in the

US.
You will orchestrate activities in engineering, clinical, RA/QA, operations, supply chain, commercialisation, and reimbursem

ent.
The Program Manager will align all outputs, identify missing elements, ensure cross-functional completeness, and continuously maintain the master project plan and deliverable inven

tory.
You will be the integration engine of the program, ensuring outcomes from different teams converge into a complete dossier, plan, and pathway toward FDA approval and commercial l

aunch.
This role reports directly to the Chief Technology Officer (CTO) and is central to our US market access st

rategy.

• 
  Why Us?Work on a breakthrough therapy that is already transformin
• g lives.Shape one of the most critical steps in the company’s journey: US marke
• t entry.Join a passionate, expert team dedicated to innovation and patient

benefit.
Respons

• ibilitiesOwn and maintain the integrated project plan across all technical, clinical, regulatory, reimbursement and operational wor
• kstreams.Own and maintain a comprehensive deliverable roadmap required for IDE, PMA, and US commercia
• lisation.Ensure all workstream outputs — design development, clinical study execution, regulatory, reimbursement, quality, clinical evidence, operations, organisational development — are complete, aligned, and sync
• hronised.Lead project - and business risk m
• anagementEnsure dependencies between outputs are well managed to prevent delays to US marke
• t access.Assure alignment of activities to comply with our internal processes and s
• tructuresProvide concise, decision-focused executive reporting to

the CTO.
Skills &

• ExperienceExcitement to roll out our innovative technology to the US and provide life-changing solutions to US epileps
• y patientsStrong program/project management skills and experience leading multidisciplinary projects in regulated env
• ironments.Experience in medical devices and direct exposure to FDA interactions—ideally including Class III devices and PMA
• pathways.Of advantage: knowledge of FDA processes, including IDE, PMA, design controls (21 CFR 820), risk management (ISO 14971), and qualit
• y systems.Strong stakeholder management and communicati
• on skills.Willingness to travel in US and Europe; be onsite in Heidelberg at least 2
• days/week.Fluent, negotiation-lev
• el EnglishDemonstrated product ownership: roadmap definition, release planning, and cross-functional l
• eadership.Experience maintaining regulatory-critical documentation as design history files, supporting submission packages, and ensuring documentation accuracy and com