At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Quality **Job Sub** **Function:** Customer/Commercial Quality **Job Category:** Professional **All Job Posting Locations:** Danvers, Massachusetts, United States of America, Remote (US) **Job Description:** **About MedTech** Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech This is a remote role available in Danvers within Massachusetts. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. **We are searching for the best talent for** **Post Market Clinical Review Specialist** **Job Description** The Clinical Review Specialist 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, Post Market Clinical Review on ensuring coding and case review objectives are relevant, compliant and meet FDA standards. **Principle Duties and 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 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 **Qualifications:** · 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 Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers . Internal employees contact AskGS to be directed to your accommodation resource. \#LI-Remote **Required Skills:** **Preferred Skills:** Audit Management, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment **The anticipated base pay range for this position is :** $94,350.00 - $127,650.00 Additional Description for Pay Transparency: The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. • 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 • Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits