International Regulatory Specialist

Found in: Jooble CA O C2 - 2 weeks ago

Kitchener ON, Canada Vena Medical Full time

Vena Medical - Regulatory Affairs Specialist  
Vena Medical is at the forefront of revolutionizing stroke treatment through cutting-edge catheter-based technologies. Our commitment to innovation has inspired our flagship products, the Vena MicroAngioscope™️ and the Vena Balloon Distal Access Catheter™️. These pioneering technologies provide neurointerventional physicians with advanced tools for treating stroke, marking a significant leap forward in medical technology. As we continue to expand our product line and impact on the medical community, we're looking for exceptional talent to join our dynamic team.

The Vena MicroAngioscope™️ is providing physicians with a new set of eyes, the world’s smallest camera that delivers a live imaging-feed from inside veins and arteries to help them treat stroke.

Regulatory Affairs Specialist
 
Hybrid – Office in Kitchener, Ontario, Canada
 
As a Regulatory Affairs Specialist at Vena Medical, you will play a crucial role in successfully navigating our cutting-edge medical devices through regulatory pathways, ensuring they meet all necessary requirements to reach the market and ultimately, save lives. You will be the liaison between the founders of Vena Medical and regulatory bodies, like the FDA, especially within the neurovascular and cardiovascular groups.

We’re open to Director, VP and Senior level candidates.
 
Lead the preparation and submission of regulatory documents directly to the FDA, focusing on catheters and/or endoscopes/intravascular imaging technologies.
Design and implement workflows for design verification and validation in compliance with regulatory standards, ensuring our products are not only innovative but also safe and effective.
Stay up-to-date on regulatory changes and trends in the medical device industry, especially those pertaining to neurovascular interventions, to inform strategic decisions.
 
Deep understanding and experience with catheter and endoscope technologies, especially within a regulatory context.
Startup mentality, with the agility and willingness to contribute hands-on in writing regulatory submissions.
Senior-level experience in regulatory affairs, demonstrating capability in developing and implementing strategies for FDA clearances.
Technical inclination, with the ability to grasp complex product functionalities and their implications on regulatory strategies.
 
Bachelor’s degree in a related field (Biomedical Engineering, Regulatory Affairs, etc.); Regulatory Affairs Certificate (RAC) or equivalent
Significant experience in regulatory roles within the medical device sector, specifically with devices related to stroke treatment and neurointerventional surgery.
Comprehensive knowledge of FDA regulatory pathways and direct experience with NRY, QJP, DQY/DQO, LYK product codes.
Demonstrated ability to develop validation and verification workflows for regulatory clearances.
 
Why Join Vena Medical?
Vena Medical is not just a workplace. It's a ground-breaking community where your work directly contributes to the advancement of medical treatments and improving patient’s lives. We offer competitive salaries, comprehensive benefits, flexible work-life balance and a supportive environment that fosters innovation and personal growth. If you're looking to make a tangible difference in the medical field, join us in paving the way for the future of neurointerventional procedures.

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