Shockwave Medical
Sr. Complaints Specialist
Shockwave Medical, Santa Clara, California, us, 95053
Description
Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical 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.
Description
Position Overview
In compliance with FDA, European MDD/MDR & other International Regulations, the Sr. Complaints Specialist will perform work under general supervision. General scope of this position is to ensure compliance to Complaints and Post Market Surveillance System, complaint initiation, assessment of regulatory reporting, investigation, filing regulatory reports, maintaining quality compliance, assisting with drafting periodic reports, and ensuring quality metrics are achieved. This position requires frequent use and proficient knowledge of industry practices, techniques, and standards.
Essential Job FunctionsEnsure 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 complaints file in an accurate and timely manner.Review adverse event reporting determinations against domestic and international regulatory requirements (FDA, EU MDD/MDR, PMDA, TGA etc.)Accurately assess risk and escalate high risk incidents to management.Complete reportability assessment and route for approvals in a timely manner.Complete and submit Vigilance Reporting, MDR and other country specific regulatory reporting documents in an accurate and timely manner.Determine if an investigation is necessary. Oversee and provide direct support of technical evaluations and investigational tasks required for complaints processing/closure in a uniform and timely manner. Determine potential cause and contributing factors to the alleged event, device relationship, whether formal device investigation is necessary.Write up complaint investigations using concise and grammatically correct English which is appropriate for regulatory review.Support service & repair events including evaluation of intake information and review of repair activities to assess whether a complaint is warranted.Assist in closing complaints in a timely and accurate manner.Ensure assigned complaint metrics are achieved (e.g. achieve target times for complaint reporting or complaint completion.)Provide guidance to other team members on dealing with potentially reportable events or complaints with inadequate information.Ensure complaints are prioritized based on patient, product, and compliance risk.Provide routine feedback to the Manager regarding the Complaints Teams' performance.
Communicate with Customers and Shockwave Medical field reps in a professional manner to gather complaint information.
Assist with training Customer and Shockwave Medical reps to ensure compliance to Shockwave Complaints/Post Market Surveillance requirements.Ensure Economic Operators are part of the Approved Supplier File.Ensure Adverse Event Reporting regulatory guidance documents are available prior to product launch in different geographies.
Assist with compiling quality metrics for trending purposes
Assist with the development and implementation complaint event tracking and trending data collection tools.Maintain QA related logs and databases (e.g. Complaints, Audit Findings etc.) when required.Assist with reports on complaint trending, complaint metrics, post market surveillance activities, Periodic Safety Reports etc.
Support New Product and New Country Introduction
Draft/revise procedures and help implement Complaint and Post Market Surveillance system changes as needed to accommodate new product and new country introductions.
Ensure compliance to the Post Market Surveillance System.
Work cross functionally and assist in drafting, reviewing, and revising periodic reports (e.g. Clinical Evaluation Report, Periodic Safety Update Report and Post Market Surveillance Report.)
Assist in continuous improvements and ongoing compliance of the Complaints, Post Market Surveillance, Regulatory Reporting and Risk Management Systems.Support Regulatory submissions by providing Post Market Surveillance data trends.Participate in quality system activities and support internal and external audits.Support company goals and objectives, policies, and procedures, QSR, and FDA regulations.Other duties as assigned.Requirements
Associate's degree with 7+ years of related quality experience; or a Bachelor's degree with 5+ years of experience is highly preferred.Experience with Medical Device Complaint handling, Post Market Surveillance and Regulatory reporting for Class II/III devices.Related Quality System Certification is a plus.Experience with FDA/ISO Audits, NCR, and CAPA experience.Proficiency in data compilation, analysis, presentation, and document writing skills.Excellent written and verbal communication skills.Working knowledge of cGMP, QSR, ISO13485 and other applicable regulations.The ability to understand and follow QMS Procedures. (e.g., SOP and Test Methods.)Experience with computer-based applications (MS Word, MS Excel, QAD).Positive mentorship experience is preferred.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.Ability to work in a fast-paced environment while managing multiple priorities.Operate as a team and/or independently while demonstrating flexibility to changing requirements.
Market Range:
$94,000 - $118,000Exact compensation may vary based on skills, experience, and location.
BenefitsShockwave Medical offers a competitive total compensation package as well as the following benefits and perks:
Core Benefits : Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance
Perks : ESPP, Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards
EEO Employer
Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical 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.
Description
Position Overview
In compliance with FDA, European MDD/MDR & other International Regulations, the Sr. Complaints Specialist will perform work under general supervision. General scope of this position is to ensure compliance to Complaints and Post Market Surveillance System, complaint initiation, assessment of regulatory reporting, investigation, filing regulatory reports, maintaining quality compliance, assisting with drafting periodic reports, and ensuring quality metrics are achieved. This position requires frequent use and proficient knowledge of industry practices, techniques, and standards.
Essential Job FunctionsEnsure 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 complaints file in an accurate and timely manner.Review adverse event reporting determinations against domestic and international regulatory requirements (FDA, EU MDD/MDR, PMDA, TGA etc.)Accurately assess risk and escalate high risk incidents to management.Complete reportability assessment and route for approvals in a timely manner.Complete and submit Vigilance Reporting, MDR and other country specific regulatory reporting documents in an accurate and timely manner.Determine if an investigation is necessary. Oversee and provide direct support of technical evaluations and investigational tasks required for complaints processing/closure in a uniform and timely manner. Determine potential cause and contributing factors to the alleged event, device relationship, whether formal device investigation is necessary.Write up complaint investigations using concise and grammatically correct English which is appropriate for regulatory review.Support service & repair events including evaluation of intake information and review of repair activities to assess whether a complaint is warranted.Assist in closing complaints in a timely and accurate manner.Ensure assigned complaint metrics are achieved (e.g. achieve target times for complaint reporting or complaint completion.)Provide guidance to other team members on dealing with potentially reportable events or complaints with inadequate information.Ensure complaints are prioritized based on patient, product, and compliance risk.Provide routine feedback to the Manager regarding the Complaints Teams' performance.
Communicate with Customers and Shockwave Medical field reps in a professional manner to gather complaint information.
Assist with training Customer and Shockwave Medical reps to ensure compliance to Shockwave Complaints/Post Market Surveillance requirements.Ensure Economic Operators are part of the Approved Supplier File.Ensure Adverse Event Reporting regulatory guidance documents are available prior to product launch in different geographies.
Assist with compiling quality metrics for trending purposes
Assist with the development and implementation complaint event tracking and trending data collection tools.Maintain QA related logs and databases (e.g. Complaints, Audit Findings etc.) when required.Assist with reports on complaint trending, complaint metrics, post market surveillance activities, Periodic Safety Reports etc.
Support New Product and New Country Introduction
Draft/revise procedures and help implement Complaint and Post Market Surveillance system changes as needed to accommodate new product and new country introductions.
Ensure compliance to the Post Market Surveillance System.
Work cross functionally and assist in drafting, reviewing, and revising periodic reports (e.g. Clinical Evaluation Report, Periodic Safety Update Report and Post Market Surveillance Report.)
Assist in continuous improvements and ongoing compliance of the Complaints, Post Market Surveillance, Regulatory Reporting and Risk Management Systems.Support Regulatory submissions by providing Post Market Surveillance data trends.Participate in quality system activities and support internal and external audits.Support company goals and objectives, policies, and procedures, QSR, and FDA regulations.Other duties as assigned.Requirements
Associate's degree with 7+ years of related quality experience; or a Bachelor's degree with 5+ years of experience is highly preferred.Experience with Medical Device Complaint handling, Post Market Surveillance and Regulatory reporting for Class II/III devices.Related Quality System Certification is a plus.Experience with FDA/ISO Audits, NCR, and CAPA experience.Proficiency in data compilation, analysis, presentation, and document writing skills.Excellent written and verbal communication skills.Working knowledge of cGMP, QSR, ISO13485 and other applicable regulations.The ability to understand and follow QMS Procedures. (e.g., SOP and Test Methods.)Experience with computer-based applications (MS Word, MS Excel, QAD).Positive mentorship experience is preferred.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.Ability to work in a fast-paced environment while managing multiple priorities.Operate as a team and/or independently while demonstrating flexibility to changing requirements.
Market Range:
$94,000 - $118,000Exact compensation may vary based on skills, experience, and location.
BenefitsShockwave Medical offers a competitive total compensation package as well as the following benefits and perks:
Core Benefits : Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance
Perks : ESPP, Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards
EEO Employer