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

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

Johnson & Johnson is seeking a Post Market Complaint Specialist (1 of 5) to be located in Danvers, MA.

This role is part of Abiomed’s Post Market Surveillance program inclusive of Regulatory reporting. Our Regulatory reporting program is designed to meet FDA’s Quality system Regulation (QSR/Good Manufacturing Practices(GMP) and globally harmonized standard ISO13485 as well as any global regulatory standards based on product geography. Based on the information received, determine if events meet appropriate regulatory requirements for adverse event reporting. Generate appropriate regulatory reports based on assessment, communicate with business partners globally, and respond to regulatory authority requests. This person will be instrumental in meeting Post Market Surveillance obligations. There will be interdepartmental interactions involving Quality Assurance Engineering, Compliance, Technical Support, Customer Service, Commercial Operations and Regulatory Affairs. The positions performs evaluations, review and submission of regulatory documents, preparation for audits and some communications with customers. There will be opportunities to showcase talent, improve, develop and continuously foster growth.

Key Responsibilities:

• Analyze and process complaints in a uniform and timely manner, to ensure proper complaint coding and accurate complaint assessment.
• Completes assessments of product complaints to determine report ability and coordinates complaint investigations between the quality assurance department, engineering, customer support and other departments.
• Support investigations and review of potential adverse events.
• Perform data entry and prepare reports/ graphs related to special projects, complaints and lot qualification as necessary.
• Process feedback letters and communications with various reporting sites.
• Support investigations and review of potential adverse events.
• Escalate complex complaint issues per department policies and guidelines.
• May prepare and/or reviews regulatory submissions and completes international vigilance reports of adverse events as required.
• Evaluates and confirms information from a technical perspective to ensure appropriate analysis, investigation, and that the root cause is documented prior to complaint closure.
• Partners with appropriate functional departments to achieve effective corrective action on severe and/or recurring problems.

Qualifications

• Bachelor’s degree or equivalent combination of education and experience with a minimum of 2+ year’s experience with data management, record keeping, and trouble shooting in Medical Device field, or other transferrable experience related to organization, technical aptitude, and data management is required.

Experience and Skills

Required:

• Knowledge of Post Market Surveillance documentation procedures and Regulatory requirements to stand on its own in the event of an audit.
• Comply with all regulatory requirements, company policies, operating procedures, processes and task assignments.
• Preparation/review and Submission of documentation of reportable events to Regulatory Authorities within required timelines.
• Support Competent Authority inquiries, Adverse Events and Serious Injury reporting and Risk Management worldwide.
• Coordinate and maintain closure of complaint records within required timelines within our Post Market Surveillance system.
• Support the review and evaluation of customer communications for complaint reporting obligations.
• Evaluates and confirms information from a technical perspective to ensure appropriate analysis, investigation, and that the root cause is documented prior to complaint closure.
• Partners with appropriate functional departments to achieve effective corrective action on severe and/or recurring problems

Preferred:

• Support investigations and review of potential adverse events.
• Escalate complex complaint issues per department policies and guidelines.
• Ability to communicate at multiple levels of an organization.
• Ability to organize and judge priorities.
• PC skill, word processing, spreadsheet, database
• Able to work effectively in a high-stress, high energy environment.
• Able to make decisions quickly based on vague information and evaluate the need to obtain clarification and direction when necessary.
• This position is a desk job and requires sitting for extended periods of time.

Other:

• English language proficiency is a requirement.
• This position may require up to a10% of domestic and/or international travel.

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 and 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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is:

$77, 000 to $124, 200

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)). This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year 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 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. http: //www.careers.jnj.com/employee-benefits