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    Sr. Regulatory Affairs Specialist - Irvine, United States - Inari Medical

    Inari Medical
    Inari Medical Irvine, United States

    2 days ago

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    Description


    The Sr. Regulatory Affairs Specialist works under minimal supervision supporting cross- functional teams with regulatory strategy and execution for new devices and device modifications.

    Responsibilities
    • Participate as the regulatory representative supporting cross-functional project teams.
    • Draft and execute regulatory strategies for new product development and device
      modifications, including identifying regulatory risks, tracking timelines and submission
      deliverables, and establishing contingency plans.
    • Support RA functional area in the review and approval of change orders, including writing
      letters to file where applicable.
    • Obtain market clearance and approvals for class II and III medical devices, including (but
      not limited) to 510(k)s, IDEs, pre-submissions and PMAs.
    • Create and review project deliverables for regulatory submissions.
    • Interact with regulatory agency authorities for initial submission and query resolution.
    • Review and approve device labeling and promotional materials.
    • Support multiple projects simultaneously.
    • Mentor other regulatory affairs specialists.
    • Support quality system changes, improvements and audits as needed.
    • Develop and maintain regulatory procedures.
    • Assist in keeping the company informed of current and proposed regulatory requirements.
    • Other duties as assigned
    Qualifications
    • Bachelor's degree required. Bachelor's degree in life sciences, engineering, or related field preferred.
    • Minimum of 5 years of experience in preparing US submissions for medical devices with bachelor's degree OR minimum 3 years of experience with advanced degree.
    • Detail oriented with well-developed writing and analytical skills.
    • Excellent, proven interpersonal, verbal, and written communication skills.
    • Experience in Microsoft Office Suite, including Word, PowerPoint, Excel.
    • Interpret subjective and complex aspects of specific regulations, with thorough understanding of multiple sets and tiers of associated regulations.
    Preferred
    • Regulatory Affairs Certification preferred.
    Inari Medical offers competitive health and wealth benefits for our employees. The base pay range for this position is $100,000 - $120,000. A range of factors, including location, skills, and experience, will be considered. Actual compensation may vary.

    Inari Medical, Inc. advises applicants that employment is subject to completion of a successful background check.
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