At eSight, we make life-changing enhanced vision devices that allow people with serious visual impairment to actually see.
The most advanced and versatile low vision assistive technology, eSight is clinically-validated and worn daily by thousands of people with legal blindness to achieve their goals. Whether it's finding a new job, pursuing a degree, travelling the world, or doing all the things that sighted people take for granted, eSight empowers our clients See New Possibilities.
You are the perfect candidate if you bring with you proven capabilities to deliver well written documentation of product specification, and managing regulatory risks, issues and changes.
Some of the things you'll be doing:
- Write and compile instructions for use / documentation in compliance with medical device labelling requirements in major jurisdictions, such as the U.S., Canada, EU, Australia, UK, and Saudi Arabia.
- Oversee compliance of product labels / packaging with medical device labelling requirements in major jurisdictions, such as U.S., Canada, EU, Australia, UK, and Saudi Arabia.
- Write and compile technical documentation to support regulatory filings and on-going compliance.
- Maintain establishment registrations / device listings in the U.S and establishment registration and device licenses in Canada, as applicable.
- Other duties as assigned.
You bring with you:
- Formal training in technical writing.
- One of the following:
- a degree in a scientific or legal field and one year of professional experience in regulatory affairs/quality management systems related to medical devices, OR
- at least 4 years of professional experience in regulatory affairs/quality management systems related to medical devices.
- Knowledge of 21 CFR, SOR 98-282 Canadian MDR, EU 2017/745 MDR.
- Experience writing regulatory submissions, such as 510(k), Health Canada licence applications, and Technical Files for CE Mark.
- Experience working with Adobe FrameMaker, InDesign, Illustrator, and Acrobat.
- Past demonstrated ability to translate technical information into well written documentation.
- Strong attention-to-detail, client-centric service instinct, and organizational skills.
At eSight we are committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require any accommodation during the application or interview process, we will work with you to meet your needs. Please contact us at 613 800 5544 x317.