Complaints Specialist II - Shockwave Medical
Johnson & Johnson MedTech, Santa Clara, CA, United States
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.
#J-18808-Ljbffr
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.
#J-18808-Ljbffr