Regulatory Affairs Specialist

2 weeks ago

Kitchener ON MA, Waterloo region, Canada Vena Medical Full time
Vena Medical - Regulatory Affairs Specialist

About Us:
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.

The Vena Balloon Distal Access Catheter™️ has combined both a distal access catheter and balloon guide catheter into one, bringing the balloon closer to the clot, reducing residual clots, increasing first-pass success rate, and cutting costs.

Position:
Regulatory Affairs Specialist

Location:
Hybrid – Office in Kitchener, Ontario, Canada

Role Overview:
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.

Key Responsibilities:
Lead the preparation and submission of regulatory documents directly to the FDA, focusing on catheters and/or endoscopes/intravascular imaging technologies.
Develop and execute comprehensive strategies for obtaining clearances for new products, with a particular emphasis on those classified under NRY, QJP, DQY/DQO, and LYK product codes.
Engage in direct interactions with FDA reviewers, utilizing your experience to foster positive relationships and facilitate the clearance process.
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.

Ideal Candidate Profile:
Deep understanding and experience with catheter and endoscope technologies, especially within a regulatory context.
Proven track record with the neurovascular group at the FDA, with experience in cardiovascular groups considered a strong plus.
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.

Qualifications:
Bachelor’s degree in a related field (Biomedical Engineering, Regulatory Affairs, etc.); advanced degree preferred.
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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