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    Principal Regulatory Affairs Specialist - Irvine, United States - Endologix

    Endologix
    Endologix Irvine, United States

    3 weeks ago

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    Description

    Overview:

    Represents the Regulatory Affairs function in project teams, and manages regulatory projects to established timelines and budgets. Oversees and ensures compliance with state, federal and International medical device regulations and overall regulatory departmental objectives. Develops, prepares, and maintains domestic and international regulatory filings and documentation to meet corporate objectives.

    Responsibilities:
    • Represent RA department in assigned project meetings and provide regulatory guidance to ensure adherence with global regulatory requirements as appropriate.
    • Maintain up-to-date knowledge on domestic and international regulatory requirements, regulations, standards, and guidances and ensure effective communication to the project teams and management.
    • In conjunction with international regulatory partners (internal and external) and Regulatory Management, develop, justify, and document sound regulatory strategies to support corporate goals.
    • Clearly identify regulatory requirements and monitor changes and regulatory intelligence on an ongoing basis.
    • Directly interact with regulatory bodies in the US and internationally in a respectful, professional manner to ensure projects remain on track and issues are identified and resolved as expediently as possible.
    • Assign and oversee completion of prioritized tasks to Regulatory Affairs specialists as appropriate.
    • Review and approve document change orders (DCOs), technical documents, test protocols and reports, risk management documents, and other documents for compliance and impact on regulatory status in applicable geographies.
    • Manage the strategy, preparation and maintenance of high quality filings to clearly documented, established timelines, including but not limited to: Letters to File (LTFs); investigational use applications; annual reports;and marketing applications.
    • Manage query resolution process using sound project management skills in collaboration with cross-functional technical teams.
    • Update departmental procedures and work instructions, as required.
    • Prepare high quality presentation materials and training materials to meet project objectives and for internal and external communication.
    • Perform other duties as assigned by Regulatory Affairs Management.
    • Up to 30% travel is anticipated.
    Qualifications:

    Education:

    • Minimum bachelors degree in a scientific discipline or equivalent.

    Experience:

    • Minimum 7 years of experience with a Bachelors degree, 5 years experience with a Master's degree of directly relevant experience in Regulatory Affairs.
    • Experience in Regulatory Affairs with US Class III cardiovascular devices strongly preferred.

    Compensation: $104,000 to $165,000.00

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