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    Regulatory Affairs - Sydney, Australia - Hengandhurst

    Hengandhurst
    Hengandhurst Sydney, Australia

    1 week ago

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    Description

    Regulatory Affairs & Quality Assurance Manager | Medical Devices | Sydney based

    • Sydney
    • Medical Device / Medical
    Thrilling times for this fast-growing ANZ medical devices company with a wide, diversified and exiting portfolio. Highly collaborative and warm team.
    • Diverse and growing portfolio across the ANZ market.
    • Opportunity to join an expanding collaborative team.
    • Great opportunity for a fast-growing long-term career.

    Become part of a thriving, independent ANZ medical device company dedicated to expanding its portfolio and product offerings. Renowned for its robust culture, seasoned professionals, and top-tier products, this company has achieved growth not only through business triumphs but also by strategically acquiring new products for distribution. As they continue to expand, they seek an ambitious and motivated Regulatory Affairs & Quality Assurance Manager.

    Reporting directly to the Director of Business Development and Operations your key responsibilities will include:

    • Develop regulatory strategies for device approval, prepare and submit applications and ensuring compliance.
    • Management and update of QMS.
    • Maintain ISO 9001 standards and conduct audits to ensure compliance.
    • Post-Market Surveillance: handle complaints, adverse events, and recalls and potentially implement corrective actions with cross-functional teams.
    • Stay updated on regulations and trends and communicate changes for timely compliance.

    To be considered for this role, you will have:

    • Bachelor's degree in a relevant scientific or engineering discipline; advanced degree is a plus.
    • Multiple years of experience in regulatory affairs and quality management within the medical devices industry.
    • Ability to work to deadlines and to prioritise accordingly with a strong attention to detail and project management capability.
    • Driven mindset, hands-on approach and supportive personality.
    • Excellent communication and interpersonal skills, with the ability to work collaboratively across departments.

    This presents a fantastic opportunity to join a top-tier medical device distribution company. Given its current business scenario, there is ample room for your growth and development. While you may not be an expert in all medical devices or quality systems, what matters most is your willingness to contribute to their exciting internal growth and readiness to face challenges. If you excel in an autonomous setting and value being part of a close-knit team, this role could be ideal for you. To apply, please click 'apply' and send your CV in word format. For further information, contactJasmineGarbino on

    #J-18808-Ljbffr
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