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    Regulatory Affairs Specialist

    Terumo Medical Corporation
    4+ years
    Not Disclosed
    Remote, USA
    10 July 19, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Regulatory Affairs Specialist

    Company: Terumo Medical Corporation

    Location: [Location]

    Type: Full-time

    Job Summary:

    The Regulatory Affairs Specialist will determine regulatory requirements and strategies for Terumo’s devices and projects, ensuring compliance with national and international regulations. This role involves preparing documents and submissions for government clearance or approval for commercial distribution of products worldwide, and serving as a liaison between Regulatory Agencies and Terumo Medical Corporation.

    Responsibilities:

    • Regulatory Compliance:

      • Follow requirements of applicable national and international regulations.
      • Analyze data and prepare documentation for submission to obtain clearance or approval for product distribution.

    • Product Development:

      • Participate in product design teams and verify compliance with design control requirements and procedures.
      • Determine regulatory requirements and strategies for new product development projects, including domestic and international activities.
      • Provide regulatory consultation to internal and external entities.

    • Documentation and Reporting:

      • Maintain documentation and historical records for projects.
      • Provide management with updated product status.
      • Supply materials and documentation for US and international product registrations and certifications.

    • Knowledge Maintenance:

      • Stay abreast of Federal USA, Canadian, MDR, and other international regulations.
      • Keep up-to-date with Regulatory Agency updates, including new policies and guidance.

    • Interdepartmental Interaction:

      • Interact with production division, federal agencies, industry organizations, and other departments.
      • Participate in project performance team meetings to contribute to performance improvement ideas and methods.

    • Regulatory Strategies:

      • Develop regulatory strategies for new products with guidance from Regulatory Management.
      • Ensure proactive contribution to the overall growth of the Regulatory Affairs department.

    • Other Duties:

      • Perform other job-related duties as assigned.

    Position Requirements:

    Knowledge, Skills, and Abilities (KSAs):

    • Strong organizational and time management skills.
    • Knowledge of GLP/GMP requirements.
    • Strong written and oral communication skills.
    • Knowledge of FDA, EU, MHLW, TGA, and other international requirements.
    • Knowledge of product labeling requirements and standards.
    • Ability for independent work, teamwork, and decision-making.
    • Ability to interpret federal laws for regulatory discipline.
    • Strong computer skills, including MS Office and Adobe Acrobat.

    Background and Experience:

    • Minimum of a 4-year degree in engineering, life sciences, or similar discipline.
    • One year of relevant experience or a combination of equivalent education, background, experience, and training.
    • Experience in a medical device quality assurance environment preferred.
    • Experience with 510(k)/IDE/PMA device submissions and/or other worldwide submissions and clearances preferred.
    • Experience with FDA requirements, guidance documents, Medical Device Directive, Medical Device Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards preferred.

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