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    Regulatory Affairs Specialist - San Diego, United States - Eastridge InfoTech

    Eastridge InfoTech
    Eastridge InfoTech San Diego, United States

    3 weeks ago

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    Description

    Eastridge Workforce Solutions is hiring a Regulatory Affairs Specialist for a c ompany that offers cloud-based laboratory testing of blood tests through a central lab before releasing them to physicians for review and discussion with their patients, as well as providing consulting services. For immediate consideration, apply today.

    About The Role

    The Regulatory Affairs Specialist will assist in regulatory submissions, interpret regulations, and provide regulatory guidance. This role will be responsible for preparing submission documents and working cross-functionally with other departments to ensure timely completion of deliverables related to regulatory submissions. This role will also be responsible for maintaining regulatory related documents.

    Essential Functions & Responsibilities

    These may include but are not limited to:

    • Write, review, and edit technical documents for regulatory submissions in a format consistent with applicable guidance documents
    • Prepare and manage Q-submissions for timely responses from the FDA
    • Assist in regulatory submissions (510(k), PMA, and CE)
    • Prepare and manage e-STAR regulatory submission requirements
    • Maintain regulatory files such as 510(k)s, PMAs, Q-Submissions, and CE dossiers for EU
    • Support preparation of labels and labeling documents for submissions
    • Work with other departments, communicate regulatory submission requirements and track submission deliverables for completion as per the project timelines
    • Provide support to the team with regulatory strategy analyses and options
    • Monitor and maintain regulatory registrations, certifications and licenses, ensuring they are accurate and up-to-date
    • Keep abreast of regulations / guidance to ensure compliance
    • Support external regulatory agency audits, providing regulatory input to minimize or prevent potential findings of non-compliance
    • Organize and maintain all regulatory related documents
    • Comply with company's QMS
    • Other duties as assigned
    Education, Experience, Knowledge, Skills, and Abilities:
    • A minimum of a Bachelor's degree in Science or related discipline and 4-5 years of experience in IVD regulatory or similar
    • Certification in regulatory affairs is a bonus
    • Excellent understanding of regulations and strong analytical and problem-solving skills
    • Excellent written and Verbal communication skills with the ability to listen, articulate and advocate
    • Strong prioritization skills, flexibility and ability to handle multiple projects simultaneously while meeting deadlines
    • Ability to communicate effectively with employees across multiple departments
    • Proficient in Microsoft Office applications - MS Word, Excel, and PowerPoint)
    • Strong organizational skills and attention to detail, along with the ability to work on a number of projects with tight timelines
    Benefits & Stock Options
    • As a valued member of the team, you'll have access to a comprehensive benefits package, including competitive salary, health, dental, and vision insurance, and flexible paid time off. Additionally, they offer stock ownership and equity participation, providing you with the opportunity to directly share in the success and growth of the company.
    Eastridge Workforce Solutions is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note that Eastridge is unable to provide visa sponsorship to applicants.

    Certain clients require Eastridge to perform background checks and Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.

    #IPROPLUS

    #LI-BL2
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