Post Market Clinical Review Specialist
OneTrust
full-time
Posted on:
Location Type: Remote
Location: Massachusetts • United States
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Salary
💰 $94,350 - $127,650 per year
About the role
- 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
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
medical writingcoding accuracyclinical rationalecomplaint intake reviewpost market clinical reviewFDA standardsclinical supportcardiology experienceAbiomed product portfolio
Soft Skills
collaborationprioritizationorganizationflexibilitytime managementconfidentialityexecutive communicationprofessionalisminfluence