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    Regulatory Affairs Specialist - Baltimore, United States - Linkedin - Jobboard

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    Position:

    Regulatory Affairs SpecialistLocation: Sparks, MDDuration: 3+ Months ContractTotal Hours/week: 40.001st shiftThe Individual Will Work With Global Colleagues To Support Korea, China, And/Or Other Countries As They Fulfill Requirements To Register ProductsRegulatory Affairs is responsible for planning, coordinating and implementing regulatory strategies for products that require government approval.

    Demonstrates working knowledge of healthcare-related regulationsDemonstrates in-depth knowledge of preparing a submissionDemonstrates in-depth knowledge of industry and competitive productsApplies relevant regulations and statutes to further product submissions of basic to medium complexityContributes to the strategic direction of regulatory pathway developmentRefines and conforms the preliminary data used in the submission processTranslates technical data and descriptions into reviewer-friendly contentHelps to ensure that the appropriate regulatory requirements for the submission are metInteracts with regulatory body to help further product approvals or clearanceHas in-depth experience, knowledge and skills in own job family Applies knowledge and skills to a wide range of standard and non-standard situationsWorks independently with minimal guidance Usually determines own work priorities Acts as a resource for colleagues with less experience#J-18808-Ljbffr


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