Post Market Clinical Review Specialist

Johnson & Johnson

Clinical Review Specialist at Johnson & Johnson handling post market clinical reviews and regulatory compliance. Collaborating with cross-functional teams to ensure adherence to FDA standards and educational support.

Posted 4/15/2026full-timeRemote • Massachusetts • 🇺🇸 United StatesMid-LevelSenior💰 $94,350 - $127,650 per yearWebsite

About the role

Key responsibilities & impact

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 customer outreach
Provide clinical support for post market engineering as needed
Collaborate with cross functional teams to provide field team education regarding the complaint handling process
Support research teams in efficiently and compliantly reporting complaints

Requirements

What you’ll need

Minimum of 5 years cardiology experience
Demonstrate effective collaboration through previous partnerships and activities
Preferred complete Abiomed product portfolio experience
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

Benefits

Comp & perks

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
o Vacation – up to 120 hours per calendar year
o Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
o Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

coding guidelinescoding accuracymedical writing

Soft Skills

collaborationprioritizationorganizationflexibilitytime managementconfidentialityexecutive communicationprofessionalisminfluence