Complaints Specialist II - Shockwave Medical

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Complaints Specialist II – Shockwave Medical to join our team located in Santa Clara, CA.

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/.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

In compliance with FDA, European MDD/MDR & other International Regulations, the Complaints Specialist II will perform work under general supervision. General scope of this position is to ensure compliance to the Complaints and Post Market Surveillance System with the responsibility of timely complaint initiation and assessment of regulatory geography reporting, complaint follow-up, coordination of complaint device returns, and collaboration with the cross-functional engineers and technicians for timely completion of the complaint investigation. The Complaints Specialist II will also be responsible for maintaining quality compliance, and ensuring quality metrics are achieved. This position requires frequent use and general knowledge of industry practices, techniques, and standards.

Essential Job Functions

• Under guidance, ensure compliance of the Complaints System to internal requirements and

• Domestic and International Regulations:

• Initiate complaints and ensure all required information are gathered and added to the complaint file accurately and in compliance with company policy.

• Communicate with Customers and Shockwave Medical field reps in a timely and professional manner to gather necessary complaint information required to complete complaint reportability assessments, and information needed for thorough investigation.

• Collaborate with Shockwave Medical Safety to review adverse events and near adverse events.

• Coordinate the return of complaint devices through the RMA (Returned Material

• Authorization) process and collaborate with the cross-functional teams to ensure timely shipment, receipt, and decontamination of devices.

• Complete complaint reporting assessments per geography regulatory medical device reporting requirements for approved devices in the US, EEA, CANADA, AUSTRALIA, BRAZIL, JAPAN, CHINA, and any other international jurisdiction as required.

• Ensure timely submission and management approval of reportability decisions in compliance with company policy.

• Escalate high risk incidents to management.

• Collaborate with the MDR/ MDV reporting team to ensure information in the complaint is accurate and complete for timely submission to the regulatory authorities within the required timeframe per applicable geography regulation.

• Ensure timely GFE (Good Faith Effort) with the complainant to obtain necessary information for timely complaint investigation and closure.

• Write up complaint event descriptions using concise and grammatically correct English which is appropriate for regulatory review.

• Retrieve relevant device identifiers such as the UDI number, component/ model number, etc. from the device lot history record (LHR).

• Ability to navigate clinical trial EDC (Electronic Data Capture) databases for pre-market and post market studies for obtaining necessary information needed for complaints.

• Assist with document revisions according to company QMS requirements.

• Support service & repair events including evaluation of intake information and review of repair activities to assess whether a complaint is warranted.

• Ensure assigned complaint metrics are achieved (e.g. achieve target times for complaint initiation, reportability assessment, MDR/ MDV Reporting, and complaint closure.)

• Ensure complaints are prioritized based on the patient outcome, regulatory reporting requirements, product, and compliance risk.

• Assist with providing feedback to Customer and Shockwave Medical reps to ensure compliance with Shockwave Post Market Surveillance requirements.

• Assist with reports on complaint metrics and post market surveillance activities.

• Ensure compliance with the Post Market Surveillance System

• Assist in continuous improvements and ongoing compliance with the Complaints, Post Market Surveillance, Regulatory Reporting and Risk Management Systems.

• Participate in quality system activities and support internal and external audits.

• Support company goals and objectives, policies, procedures, QSR, and domestic and international medical device regulations

• J&J Credo: Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in dayto-day interactions with team.

• Other duties as assigned.

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

Requirements

• Associate’s degree with 4+ years of related Post Market Surveillance experience or a Bachelor’s degree with 2+ years of related Post Market Surveillance experience.

• Experience with Medical Device Complaint handling, Post Market Surveillance and Regulatory reporting for Class II/III devices is required.

• Experience with FDA/ISO Audits, NCR, and CAPA experience is a plus.

• Proficiency in data compilation, analysis, presentation, and document writing skills.

• Excellent written and verbal communication skills.

• The ability to understand and follow QMS Procedures. (e.g., SOP and WI’s)

• Proficient with computer-based applications (MS Word, MS Excel, MS PowerPoint).

• Strong interpersonal skills and ability to provide good customer service support.

• Strong time management skills and the ability to multi-task in a fast-paced environment.

• Operate as a team and/or independently while demonstrating flexibility to changing requirements.

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, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing

The anticipated base pay range for this position is :

$75,000.00 - $120,750.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are 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.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year

Holiday pay, including Floating Holidays –13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave – 80 hours in a 52-week rolling period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits