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    Regulatory Reporting Specialist Medical Device (Immediate Joiner Only)

    Akkodis
    5+ years
    Not Disclosed
    Remote
    10 May 22, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title:

    [Position Title]

    Key Skills:

    • MedWatch Reports: Proficient in creating and managing MedWatch reports.
    • 21 CFR Part 803: In-depth knowledge of FDA regulations for medical device reporting.
    • Regulatory Reporting: Expertise in preparing and submitting regulatory reports.
    • Adverse Events: Experienced in identifying and reporting adverse events.
    • Product Problems: Skilled in assessing and documenting product problems.
    • Complaint Management: Proficient in managing and assessing complaints.

    Qualifications:

    • Experience: 5+ years of experience in Information Technology.

    Requirements:

    • Thorough understanding of MedWatch reporting processes.
    • Extensive knowledge of 21 CFR Part 803 regulations.
    • Proven experience in regulatory reporting and compliance.
    • Ability to assess and report adverse events and product issues.
    • Strong complaint management skills, including assessment and documentation.

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