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    Stage - Compliance Analyst - Kitchener, ON, Canada - Intellijoint Surgical Inc.

    Intellijoint Surgical Inc.
    Intellijoint Surgical Inc. Kitchener, ON, Canada

    1 week ago

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    Description
    Contribute towards safe and effective products at a fast-growing medical technology company Type of Position: Full Time
    Kitchener HQ – In office presence required 3-days per week

    Today, Intellijoint technology lives in the operating room, helping surgeons improve implant positioning during hip and knee replacement surgeries.

    We are seeking a Quality Assurance & Regulatory Affairs (QARA) Analyst to join our QARA team to help bring innovative technologies to the market.

    As part of the Quality Assurance and Regulatory Affairs (QA/RA) Team, the QA/RA Analyst plans and implements quality assurance and regulatory affairs activities required for timely completion and sale of Intellijoint Surgical medical devices in a regulated environment.

    As an integral member of the team, the QA/RA Analyst collaborates with internal and external parties, ensuring compliance with our internal Quality Management System (QMS) requirements.

    Thrives in a policy and procedural driven environment; detail oriented, organized and diligent in adherence to policies and procedures
    A continuous learner that builds on their existing knowledge of medical device and biomedical technology regulations
    Support product design, development and production via risk management, analysis, compliance, stakeholder engagement and process excellence.

    Act as a key stakeholder and liaison with regulatory bodies in the submission of regulatory documents required for product approval and registration in various markets.

    Conduct comprehensive regulatory impact assessments for product changes, ensuring continuous compliance with international standards such as MDSAP, FDA QSR, EU MDR, etc.

    Contribute to and lead the development and improvement of internal processes and the quality management system by participating in audits, implementing advanced metrics, and analyzing data for continuous quality and regulatory enhancement.

    Lead the review and approval process for more complex product records and quality documentation, ensuring compliance with specified requirements.

    Contribute to the development and improvement of internal processes and the quality management system by participating in audits, implementing advanced metrics, and analyzing data for continuous quality and regulatory enhancement.

    Collaborate with the supply chain team to qualify suppliers, conduct audits, and ensure suppliers meet the required quality and regulatory standards.

    Conduct post-market surveillance activities, analyzing data from various sources (customer feedback, complaints, field reports) to identify potential product issues or trends, in line with regulatory requirements.

    Coordinate the investigation and reporting of adverse events or other reportable incidents to regulatory authorities in compliance with global regulations.

    Bachelor's degree in a related field is required; a postgraduate certification in Regulatory Affairs and/or Quality Assurance is highly advantageous.

    ~3+ years of relevant experience in a regulated industry, with a strong focus on medical devices.
    ~ Demonstrated experience in regulatory submissions, quality system management, and compliance with international medical device regulations and standards.
    ~ Strong analytical skills, with the ability to interpret regulatory guidelines and integrate them into business processes.
    ~ Proficient in using industry-standard software and systems, with a keen ability to adapt to new technologies.
    ~ Strong communication skills, capable of effectively collaborating with diverse teams and championing compliance across the organization.

    Work on innovative products that improve surgical outcomes and enhance patient's quality of life.
    Work in an environment with high transparency and collaboration along with lots of fun and social activities.
    It is our policy to recruit and select applicants solely on the basis of their qualifications.

    We are an equal opportunity employer that hires talent regardless of age, race, creed, colour, religion, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, or any other status or condition protected by applicable law.

    Those in need of accommodation at any stage in the recruitment process should notify .
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