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    Regulatory Affairs Senior Associate - Mississauga, ON, Canada - Boston Scientific Gruppe

    Boston Scientific Gruppe
    Boston Scientific Gruppe Mississauga, ON, Canada

    3 weeks ago

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    Description
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    Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

    At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges.

    With access to the latest tools, information and training, we'll help you in advancing your skills and career. Please note this is a 1-year contract opportunity.

    The Regulatory Affairs Senior Associate supports the Manager, Regulatory Affairs in ensuring rapid and timely approvals for respective product lines.

    This involves planning for all product registration and managing all product registrations' preparation and documentation.

    Furthermore, they will interact with regulatory agency personnel to expedite approval of pending registration as well as answer any questions on product documentation.

    Plan, organize, assemble and file medical device license applications and regulatory dossiers to Health Canada, FDA and EU Notified Body
    Develop and communicate regulatory affairs strategy for new product introduction and other projects
    Assist with regulatory assessment of new products and changes made to the product
    Review of design history file documents and advise R&D team on regulatory requirements
    Stay abreast of regulatory changes
    Adhere to and promote the adherence to all Corporate, Quality and Health and Safety policies and procedures
    4+ years of relevant experience in the medical device industry
    Sound knowledge of Canadian, US, and EU regulations and guidelines for medical devices
    Sound knowledge of medical device development process and design control requirements, including risk management
    Master's degree in Life Science or related field
    Post Graduate Certificate in Regulatory Affairs
    Ability to adapt and be flexible, positive attitude and excellent interpersonal skills
    Excellent writing skills, as demonstrated through submission writing experience

    As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life.

    Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.

    Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

    So, choosing a career with Boston Scientific (


    NYSE:
    BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you

    Regulatory Affairs, Medical Device, Compliance, R&D, Law, Legal, Healthcare, Research
    SAP as service provider
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