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    Regulatory Affairs Associate II - Seattle, United States - INBIOS Intl

    INBIOS Intl
    INBIOS Intl Seattle, United States

    2 weeks ago

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    Description

    Are you a problem-solver? A collaborator? Ready to tackle the world of infectious diseases? InBios is looking for people who value a sense of community, cooperation and camaraderie with a shared vision of delivering impactful solutions to those affected by infectious diseases. At InBios, your ideas are valued, your voice is heard, your accomplishments are celebrated.

    ABOUT INBIOS

    InBios International Inc. specializes in the design, development and manufacture of diagnostic assays for emerging infectious diseases and biothreats. Founded in 1996 in Seattle, WA, InBios is dedicated to delivering superior quality products that are accurate, easy to use and cost effective. We have a portfolio of more than 25 diagnostic products, as well as an extensive catalog of life science reagents. For more information, visit

    Our primary location is in the dynamic neighborhood of South Lake Union in a state-of-the-art biotech facility, and our secondary location is in the SODO neighborhood with newly remodeled lab and office space in an historic building next to Lumen Field. InBios offers competitive wages and a rich benefit package that includes medical, dental and vision insurance, 401(k), and performance-based rewards. InBios is committed to work/life balance and provides paid vacation and sick time, including a weeklong, paid shutdown in December.

    ABOUT YOU

    We are seeking a mindful and diligent individual with experience in all aspects of regulatory affairs as it pertains to in-vitro diagnostic products. A solid understanding of immunoassays is required as well as molecular assays and associated FDA regulations. The ability to keep abreast with the ever-changing FDA and international regulations to position product for domestic and international marketing is key. If you enjoy leading and collaborating on projects, performing a variety of tasks, and working with the FDA and other regulatory bodies, and being part of a reliable and dedicated Regulatory Affairs team, then we encourage you to apply for this position.

    Experience and knowledge needed to be successful in this position:

    BS/MS in life sciences or bioengineering, and at least 5 years of experience in an FDA-regulated IVD manufacturing company or a Ph.D. with 2 years of experience.

    Certification in regulatory affairs preferred.

    Excellent knowledge of US and international IVD regulations.

    Strong written and verbal communication skills.

    High attention to detail.

    Technical system skills (e.g., MS Office, SharePoint, statistical packages, online research).

    Ability to manage multiple projects and deadlines.

    Strong understanding of statistical analysis.

    Ability to identify compliance risks and escalate when necessary.

    Prior experience in regulatory submissions (pre-submissions, EUA, 510(k), De Novo, PMA) for lateral flow and real-time PCR assays is required.

    Job duties include:

    Represent and/or lead Regulatory Affairs in project teams throughout product life cycle.

    Write/review protocols for analytical studies in support of regulatory submissions.

    Assist in the preparation and submission of EUAs, pre-submissions, 510(k)s for class II products.

    Support international registrations, create and maintain technical files, and prepare product dossiers.

    Prepare and maintain Design History Files.

    Lead Risk Management effort.

    Prepare and review labeling and marketing materials to ensure regulatory compliance.

    Help set the regulatory strategy for new product development.

    Keep abreast with the latest regulatory requirements and trends.

    Communicate with the FDA and other regulatory bodies concerning product submissions.

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