Complaints Specialist II - Shockwave Medical

Johnson & Johnson MedTech; Santa Clara (CA); Presencial; USD 75.000 - 120.750; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Vacation: 120 hours per year

Sick time: 40 hours per year

Holiday pay: 13 days per year

Parental Leave: 480 hours

Volunteer Leave: 32 hours per year

Descripción de la vacante

A leading medical technology company is seeking a Complaints Specialist II in Santa Clara, CA. The role requires ensuring compliance with regulatory standards for medical devices. Responsibilities include initiating complaints, collaborating with teams, and reporting regulatory metrics. Ideal candidates should have a degree alongside several years of relevant experience, with strong communication and data analysis skills. Competitive compensation and substantial benefits are offered.

Formación

• Experience with FDA/ISO audits is a plus.
• Ability to understand QMS procedures.
• Can work as a team member or independently.

Responsabilidades

• Ensure compliance with the Complaints System.
• Initiate complaints and gather required information.
• Collaborate with Safety on adverse events.

Conocimientos

Medical Device Complaint handling

Post Market Surveillance

Regulatory reporting

Data compilation and analysis

Excellent written and verbal communication

Strong interpersonal skills

Time management

Educación

Associate's degree with 4+ years of experience

Bachelor's degree with 2+ years of experience

Herramientas

MS Word

Excel

PowerPoint

Descripción del empleo

Overview

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.

About the Role

We are hiring a Complaints Specialist II – Shockwave Medical to join our team located in Santa Clara, CA. The role focuses on compliance with FDA, European MDD/MDR, and other international regulations, ensuring accurate complaint initiation, reporting, and investigation for Shockwave Medical’s intravascular lithotripsy (IVL) devices.

Position Overview

The Complaints Specialist II will work under general supervision, ensuring compliance with the Complaints and Post Market Surveillance System. Key responsibilities include timely complaint initiation, regulatory reporting, coordination of device returns, and collaboration with cross‑functional teams. The position also involves maintaining quality metrics and participating in audits.

Essential Job Functions

• Ensure compliance of the Complaints System to internal requirements and domestic/international regulations.
• Initiate complaints and gather all required information for accurate filing.
• Communicate with customers and field representatives to obtain complaint details.
• Collaborate with Shockwave Medical Safety on adverse events and near events.
• Coordinate return of complaint devices via the RMA process and ensure timely shipment, receipt, and decontamination.
• Report complaints per geographical regulatory requirements for approved devices in the US, EEA, Canada, Australia, Brazil, Japan, China, and other jurisdictions.
• Submit and manage reportability decisions in compliance with company policy.
• Escalate high-risk incidents to management.
• Work with the MDR/MDV reporting team to ensure accurate and complete information for regulatory submission.
• Maintain Good Faith Effort with complainants to gather necessary information.
• Write concise, grammatically correct complaint event descriptions for regulatory review.
• Retrieve device identifiers such as UDI number and component/model numbers from the lot history record.
• Navigate clinical trial EDC databases for pre‑market and post‑market studies to obtain complaint information.
• Assist with document revisions per QMS requirements.
• Support service and repair events to assess complaint warrants.
• Achieve assigned complaint metrics, such as target times for initiation, assessment, reporting, and closure.
• Prioritize complaints based on patient outcome, reporting requirements, product, and risk.
• Provide feedback to customers and reps to ensure Shockwave Post Market Surveillance compliance.
• Assist with reports on complaint metrics and post‑market surveillance activities.
• Support continuous improvements in 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/international medical device regulations.
• Apply Johnson & Johnson’s Credo and Leadership Imperatives in day‑to‑day interactions.
• Other duties as assigned.

Requirements

• Associate’s degree with 4+ years of related Post Market Surveillance experience or a Bachelor’s degree with 2+ years of related experience.
• Experience with Medical Device Complaint handling, Post Market Surveillance, and regulatory reporting for Class II/III devices.
• Experience with FDA/ISO audits, NCR, and CAPA is a plus.
• Proficiency in data compilation, analysis, presentation, and document writing.
• Excellent written and verbal communication skills.
• Ability to understand and follow QMS procedures (e.g., SOPs and WIs).
• Proficient with computer applications (MS Word, Excel, PowerPoint).
• Strong interpersonal skills and customer‑service orientation.
• Strong time‑management skills and ability to multi‑task in a fast‑paced environment.
• Can work as a team member or independently, adapting to changing requirements.

Desired Skills

Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Detail‑Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control, Quality Management Systems, Regulatory Environment, Report Writing.

Compensation

The anticipated base pay range for this position is: $75,000.00 - $120,750.00.

Benefits

• Vacation: 120 hours per calendar year
• Sick time: 40 hours per calendar year (48 hours in Colorado, 56 hours in Washington)
• 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 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 period
• Volunteer Leave: 32 hours per calendar year
• Military Spouse Time‑Off: 80 hours per calendar year
• Eligibility for the company’s consolidated retirement plan (401(k)), long‑term incentive program, and other benefits per company policies.

Equal Opportunity Employment

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. 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.