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Regulatory Reporting Specialist Medical Device (Immediate Joiner Only)

5+ years
Not Disclosed
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.