Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
Sentec is a market leader of non-invasive respiratory monitoring solutions who develops,
manufactures, and markets patient-centric, cost-effective technologies and products that provide
clinicians with greater insight to quickly identify trends, rapidly and more accurately assess patient
respiratory status, and make more well-informed, timely care decisions – decisions that can improve
patient care. We aim to improve the lives of patients by advancing non-invasive patient care by
empowering clinicians with clinically superior monitoring and therapeutic technologies.
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Summary:
Responsible for registrations of Sentec products in the US and Canada, the Regulatory Affairs
Specialist acts as the local representative and contact person for the competent authorities. Will work
closely in conjunction with, and as an extension of, the Sentec regulatory compliance team based in
Switzerland.
Essential Duties and Responsibilities:
strategies, testing requirements, and other documentation to ensure that regulatory
submissions are prepared and approved to meet launch timelines for new and modified
products.
Life at Sentec
Sentec employees have access to competitive benefits packages, paid parental leave, tuition
reimbursement and more. Sentec offers a place to thrive and make an impact as a small company with
huge potential and an expanding track-record of consistent growth. We know our decisions matter to
the future of the company, our voices are heard by leadership and our hard work pays off.
Sentec consists of an eclectic group of people dedicated to help deliver products to healthcare
providers that make a difference and improve patient care. We love that we can log off each day
knowing we’ve made a difference.
To apply, send your resume to jobs.us@sentec.com