At a Glance
- Tasks: Lead regulatory strategies for innovative medical devices and ensure compliance with FDA and international standards.
- Company: PASCALL Systems, a pioneering medical device company in Cambridge.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Dynamic work environment with a focus on innovation and teamwork.
- Why this job: Join a small team making a big impact in the medical field with cutting-edge technology.
- Qualifications: Experience in regulatory affairs and strong collaboration skills required.
The predicted salary is between 82800 - 101200 $ per year.
PASCALL Systems is a Cambridge‑based medical device company advancing EEG‑based anesthesia monitoring.
We seek a Regulatory Affairs professional to translate product strategy into regulatory strategy, maintain submissions, and ensure alignment with FDA and international standards.
The role requires independent judgment in a small team and cross‑functional collaboration.
Responsibilities include defining regulatory strategies with the CEO, preparing 510(k) materials, and supporting clinical
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Regulatory Affairs Lead, Medical Devices – Hybrid employer: Pascall Systems, Inc.
PASCALL is an exceptional employer that fosters a collaborative and innovative work culture, where Software Engineers are empowered to shape the future of medical technology. Located in Cambridge, MA, our team enjoys a hybrid work environment, competitive benefits, and ample opportunities for professional growth, all while contributing to meaningful advancements in patient care. Join us to be part of a passionate team that values creativity and encourages you to tackle complex challenges head-on.
