26 days old

Regulatory Affairs Specialist

Medline Industries, Inc.
Northfield, IL 60093
  • Job Code
    QUA0101IG
    JOB SUMMARY:

    Under general supervision, the Regulatory Specialist is responsible for planning and executing operational regulatory activities necessary to store and distribute HME/DME products. Supports HME/DME license applications including analyzing application requirements and gathering necessary information and documents. Prepare comprehensive regulatory strategies for HME/DME product distribution ensure the content, context, organizations and quality of supporting information is sufficient to meet all regulatory requirements, commitments, and agreements. May review complex regulatory issues with RA management and other team members by applying their specialized experience to solve issues and complete short-term department goals.

    MAJOR RESPONSIBILITIES:

    • In support of business priorities, determine the requirements for completing and maintaining HME/DME licensing submissions and regulatory filings for storage and distribution.
    • Communicate requirements of regulations to internal or external customers. Recommend regulatory pathways and strategies.
    • Review and provide feedback on documentation and supporting evidence to ensure applicable regulatory requirements are met.
    • Complete and maintain regulatory filings by collaborating with internal and external groups, evaluating supporting technical in-formation, writing appropriate summary documentation, and supporting the response to non-conformances and questions from regulators.
    • Present project objectives with team members, solve problems, and act as a regulatory resource and subject matter expert.

    Education

    • B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related.
    Work Experience
    • 2 years of experience in HME/DME licensing, regulatory affairs or quality assurance.
    Knowledge / Skills / Abilities
    • Understanding of the current Regulatory environment and demonstrating the ability to perform within.
    • Applied knowledge of FDA regulations and guidelines or state licensing and distribution requirements.
    • Ability to evaluate information to determine compliance with standards, laws, and regulations.






    Posted: 2022-09-09 Expires: 2022-10-08
    Sponsored by:
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    Sponsored by:
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    Regulatory Affairs Specialist

    Medline Industries, Inc.
    Northfield, IL 60093

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