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European Union Regulatory Affairs, Medical Device, Postmarket Surveillance, Quality/Risk Management
4 Year Degree
We are seeking US-based applicants to fill a Medical (Technical) Writer position for our Nox Medical business unit. Nox Medical produces medical devices for sleep diagnostics including the Nox T3 Sleep Monitor, Nox A1 PSG System, Noxturnal Sleep Software and related accessories, such as the renowned Nox RIP Belts and Nox Cannulas.
The Nox Medical Writer should have demonstrated expertise in authoring and maintenance of Clinical Evaluation Files (to include, but not limited to Clinical Evaluation Reports, Post-Market Clinical Follow-up (PMCF) Plans, and Literature Search Procedures) and all applicable SOPs necessary to comply with MDD and MDR. Additional responsibilities include:
-participate in post-market surveillance activities and planning and writing periodic safety update reports (PSUR)
-support company transition to compliance with EU Medical Device Regulation (MDR)
-assist with updates to risk management files especially in regard to clinical benefit/risk
-provide support during internal and external audits
-BS in technical/scientific discipline with 4+ years of employment in the medical device industry with experience in medical writing (CEP, CER, PMCF, PSUR)
-Demonstrable knowledge of EU and other international regulations pertaining to Clinical Evaluation, particularly EU MDR
-Ability to work independently with minimal supervison
Telecommuting is allowed.
Internal Number: 5000
About Nox Health
Nox Health is the global sleep health leader committed to helping people wake up to brighter world using proven, people-centered solutions that address the global sleep epidemic. Under the Nox Health brand, nearly 300 employees make up our business units: Nox Medical, SleepCharge and FusionSleep. Our employees are passionate about sleep and committed to helping others understand and take control of their own sleep health.
Currently, more than 2 million people a year, receive care based on data collected with Nox Health technology and hundreds of thousands of employees in US companies have access to SleepCharge.
In addition to our remote workforce, Nox Health has offices near Atlanta, Georgia and in Reykjavik, Iceland.