Post Market Clinical Review Specialist

Medical ReviewerMedical ReviewerFull TimeRemoteTeam 1,001-5,000H1B SponsorCompany SiteLinkedIn

Location

Massachusetts

Posted

34 days ago

Salary

$94.4K - $127.7K / year

Bachelor Degree5 yrs expEnglish

Job Description

• Serve as clinical expert for the complaint intake review process • Provide clinical rationale linking patient clinical presentation, procedural events, and product interaction • Serve as a clinical resource for cross functional teams including engineering, quality, and innovation excellence • Work under the supervision of the Associate Director, Post Market Clinical Review • Ensure coding and case review objectives are relevant and compliant with FDA standards • Collaborate with the post market complaint operations and regulatory review teams • Review complaint intakes for coding accuracy • Provide written narratives to meet FDA standards • Collaborate with the Medical Safety Office and Medical Office • Provide clinical support for post market customer outreach • Provide clinical support for post market engineering as needed • Collaborate with cross functional teams for field education regarding complaint handling • Support research teams in efficiently reporting complaints

Job Requirements

  • Minimum of 5 years cardiology experience
  • Demonstrate effective collaboration through previous partnerships and activities
  • Preferred complete Abiomed product portfolio experience
  • Keen sense of prioritization, organization, flexibility, and time management
  • Able to maintain confidentiality and safeguard materials and information
  • Possess executive communication skills
  • Demonstrates high level of professionalism
  • Ability to influence cross functional teams
  • Proficiency in medical writing skills
  • Proficiency with Microsoft office programs required

Benefits

  • medical, dental, vision, life insurance
  • short- and long-term disability
  • business accident insurance
  • group legal insurance
  • consolidated retirement plan (pension)
  • savings plan (401(k))
  • up to 120 hours vacation per calendar year
  • up to 40 hours sick time per calendar year
  • holiday pay including Floating Holidays – up to 13 days per calendar year
  • Work, Personal and Family Time - up to 40 hours per calendar year

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