About the role
This role will serve as clinical expert for the complaint intake review process. They will provide clinical rationale linking patient clinical presentation, procedural events, and product interaction. They will serve as a clinical resource for cross functional teams including engineering, quality, and innovation excellence. They will work under the supervision of the Associate Director on ensuring coding and case review objectives are relevant, compliant and meet FDA standards.
DUTIES & RESPONSIBILITIES
- Collaborate with the post market complaint operations and regulatory review teams to ensure coding guidelines are adhered to
- Review complaint intakes for coding accuracy and provide written narratives to meet FDA standards
- Collaborate with the Medical Safety Office and Medical Office to provide updated guidelines to the Coding Guide
- Provide clinical support for post market engineering as needed
ROLE REQUIREMENTS
- Minimum of 5 years cardiology experience preferred
- Demonstrate effective collaboration through previous partnerships and activities
- Must have a keen sense of prioritization, organization, flexibility, and time management to ensure maximum effectiveness for the benefit of the team.
- Able to maintain confidentiality, establish secure filing procedures and safeguard materials and information required
- Possess executive communication skills • Demonstrates high level of professionalism
- Ability to influence cross functional teams in a constructive manner
- Proficiency in medical writing skills
- Proficiency with Microsoft office programs required
EDUCATIONAL QUALIFICATIONS
- BS in Nursing
- Registered Nurse