Jobs
>
Kitchener

    REMOTE Regulatory Affairs Specialist - Kitchener, ON, Canada - Vena Medical

    Vena Medical
    Vena Medical Kitchener, ON, Canada

    2 weeks ago

    Default job background
    Description
    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 worlds 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.

    Were 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.

    Bachelors 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 patients 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.

  • FluidAI Medical

    Regulatory Affairs Specialist

    1 week ago

    FluidAI Medical Kitchener, Canada

    **Job Title: Regulatory Affairs Specialist** · **Company Description**: · FluidAI Medical is a medical device organization creating a paradigm shift in post-operative care, utilizing the plethora of data within the body, to help in the detection of post-operative complications at ...

  • Vena Medical

    Regulatory Affairs Specialist

    5 days ago

    Vena Medical Kitchener, ON, Canada

    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 MicroAngioscopeTM and the Vena Ba ...

  • Vena Medical

    Regulatory Affairs Specialist

    4 days ago

    Vena Medical Kitchener, Canada

    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 MicroAngioscopeTM and the Ve ...

  • Vena Medical

    Regulatory Affairs Specialist

    1 week ago

    Vena Medical Kitchener, Canada

    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 ...

  • Vena Medical

    Regulatory Affairs Specialist

    1 week ago

    Vena Medical Kitchener, Canada

    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 MicroAngioscopeTM? and the Vena ...

  • Vena Medical

    REMOTE Regulatory Affairs Specialist

    3 weeks ago

    Vena Medical Kitchener, ON, Canada

    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 MicroAngioscopeTM and the Vena Balloon ...

  • McArthur Medical Sales Inc.

    Regulatory Affairs and Quality Assurance Specialist

    1 week ago

    McArthur Medical Sales Inc. Rockton, Canada

    Regulatory Affairs and Quality Assurance Specialist I supports, maintains, and continuously improve Quality Management System and Regulatory needs of McArthur Medical Sales Inc (MMSI) operations. · **Responsibilities**: · PRIMARY DUTIES AND RESPONSIBILITIES: · - Performs and coor ...

  • MEDA

    Communications Specialist

    3 weeks ago

    MEDA Waterloo, Canada

    **Position Summary** · Reporting to the Director, Corporate and Creative Communications, the Communications Specialist will support MEDA's external communication strategy by writing and co-creating content for digital channels, positioning MEDA as a leader in economic development ...

  • University of Waterloo

    Student Service Specialist

    3 weeks ago

    University of Waterloo Waterloo, Canada

    Overview: · **Term: 1 year.** · The Student Service Centre (The Centre) is a unique one-stop service unit for undergraduate and graduate students that allows them the opportunity to have many of their non-academic needs met in one place. Partner departments include the Registrar' ...

  • University of Waterloo

    Services Support Specialist

    3 weeks ago

    University of Waterloo Waterloo, Canada

    Overview: · **Term: 2 years** · The Services Support Specialist reports to the Services Manager and supports the overall success of all student-run services. The role provides direct supervision of 4-6 student-run services as assigned by the Services Manager. These services are u ...

  • University of Waterloo

    International Communications Specialist

    3 weeks ago

    University of Waterloo Waterloo, Canada

    Overview: · Reporting to the Associate Director, International Operations, the International Communications Specialist will plan, implement, and evaluate an integrated marketing and communications program for the purposes of advancing the Waterloo International (WI) and the Unive ...

  • University of Waterloo

    International Community Engagement Coordinator

    2 weeks ago

    University of Waterloo Waterloo, Canada

    Overview: · **Term: 18 months** · The International Community Engagement Coordinator is accountable to the Specialist, International Student Programs. The coordinator is responsible for the overall development, coordination, implementation, and evaluation of comprehensive and int ...

  • Essential HR

    Jr Content Coordinator

    3 weeks ago

    Essential HR Waterloo, Canada

    Are you fiercely creative and know how to get people talking? Are you driven to craft solutions and tell stories in unique and out-of-the-box ways? · At Durrell Communications we pursue excellence in being the voice of our clients, and we are looking for our newest creative team ...

  • University of Waterloo

    Project Manager, New Student Transition

    3 weeks ago

    University of Waterloo Waterloo, Canada

    Overview: · The Project Manager, New Student Transition is responsible for the coordination and implementation of comprehensive and intentional pre-arrival transition programs for a diverse group of first-year students. This includes developing, coordinating, and delivering progr ...

  • Covanta

    Customer Care Specialist I

    2 weeks ago

    Covanta Kitchener, Canada

    Who we are · For more than 40 years, Covanta has been at the forefront of sustainable materials management, providing companies and communities world-class waste and resource solutions. · Through our diverse and scalable full-service capabilities, we're leading the charge to a ca ...

  • Nutrablend Foods

    Regulatory & Scientific Affairs Specialist

    2 weeks ago

    Nutrablend Foods Cambridge, Canada

    Meet Nutrablend Foods · Nutrablend Foods is one of the largest custom manufacturers of specialized health nutrition powder products in North America, powered by an experienced team with a passion to help customers hustle and thrive. · With over 20 years working with some of the t ...

  • University of Waterloo

    Quality Assurance Coordinator, New Programs and

    2 weeks ago

    University of Waterloo Waterloo, Canada

    Overview: · The Quality Assurance Coordinator — New Programs and Research (QAC-NPR) reports to the Director, Academic Quality Assurance and Continuous Improvement (AQACI). The Coordinator plays three primary roles: (1) providing in-depth support during the development of new prog ...

  • Wilfrid Laurier University

    Wellness Education Coordinator

    2 weeks ago

    Wilfrid Laurier University Waterloo, Canada

    **Date**:Jul 20, 2023 · **Location**: Waterloo, CA · **Company**:Wilfrid Laurier University · **Department**: Student Affairs · **Job Type**: Continuing · **Full-time/Part-time**: Full Time (>=1249 hrs/year) · **Campus**: Waterloo · **Reports to: Manager, Wellness Education** · * ...

  • Nutrablend Foods

    Regulatory & Scientific Affairs Specialist

    2 weeks ago

    Nutrablend Foods Cambridge, Canada

    Meet Nutrablend FoodsNutrablend Foods is one of the largest custom manufacturers of specialized health nutrition powder products in North America, powered by an experienced team with a passion to help customers hustle and thrive.With over 20 years working with some of the top Spo ...

  • University of Waterloo

    International Student Transition Coordinator

    1 day ago

    University of Waterloo Waterloo, Canada

    Overview: · The International Student Transition Coordinator is accountable to the Specialist, International Student Programs and is responsible for the overall development, coordination, implementation and evaluation of comprehensive and intentional pre-arrival and transition pr ...