Complaints Specialist II
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 Complaints Specialist II will perform work under general management 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 filing MDR/MDV reports to applicable geography regulatory authorities, 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 in an accurate and timely manner.
- Communicate with Customers and Shockwave Medical field reps in a timely and professional manner to gather necessary complaint information
- Coordinate the return of complaint devices for investigation (where applicable), and collaborate with the cross-functional engineers to ensure timely investigation and risk assessment of each complaint.
- Complete adverse event reporting determinations per geography regulatory requirements for approved devices (FDA, EU MDD/MDR, PMDA, TGA etc.) and route for approval in a timely manner.
- Escalate high risk incidents to management.
- Complete MDR/ MDV reports in an accurate and timely manner and ensure they are submitted to the regulatory authorities within the required timeframe per applicable geography regulation.
- Provide support of technical evaluations and investigational tasks to ensure complaints are investigated and closed in a timely manner.
- 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.
- 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.
- Participate in Customer and Shockwave Medical rep training to ensure compliance to Shockwave Complaints/Post Market Surveillance requirements.
- Assist with reports on complaint trending, complaint metrics, post market surveillance activities, Periodic Safety Reports etc.
- Participate in the summary and communication complaint trend data to cross-functional teams
- Ensure compliance to the Post Market Surveillance System
- Assist in continuous improvements and ongoing compliance of the Complaints, Post Market Surveillance, Regulatory Reporting and Risk Management Systems.
- Participate in quality system activities such as CAPAs, DCOs, 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 4+ years of related quality experience or a Bachelor’s degree with 2+ years of related quality 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.
Market Range:
$75,000 - $94,000
Exact compensation may vary based on skills, experience, and location.
Benefits
Shockwave 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: Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards
EEO Employer