Senior Manager, Clinical Product Quality - Post Market Quality & Complaints

Please note this is an "onsite" role, and the successful candidate will be expected to work from our Naperville, IL office.

Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

The Senior Manager, Clinical Product Quality will plan and lead initiatives around Post-Market Quality Assurance, specifically Complaint Handling, assuring appropriate investigation and documentation of product complaints, including reporting of events to regulatory Agencies. Provide Medical/Clinical Guidance to Complaint Staff and Engineers to understand the nature of complaints and possible health risks.

How you will make an impact:

• Provide medical/clinical guidance to complaint staff and engineers related to event interpretation, event investigation, proper coding, and required regulatory reporting (MDR, MDV, etc.).
• Review and approve global reporting decisions, MDRS/MIRs prior to submission, and complaints for closure.
• Obtain and evaluate information from clinical specialists, sales staff, physicians, nurses and other hospital staff/customers, as needed to support complaint investigation and drive towards resolution.
• May provide training to complaint staff on patient anatomy and medical conditions, products and
  procedure, and internal policies and procedures.
• Develop and plan Medical/Clinical Guidance projects and activities with accountability for successful completion of all project deliverables.
• Educates complaint staff to understand nature of complaints and possible health risks; Interprets complaint data for Quality compliance staff, complaint investigators and other Quality department personnel.
• Authors clinically based product specific scripts to guide complaint handlers in appropriate investigation.
• Provide Clinical input for quality escalations, risk assessments, nonconformances and CAPAs.
• Provide direction and guidance to project teams to execute tactical clinical product quality projects and/or initiatives.
  Identify and evaluate clinical product quality process improvement and/or course correction/course alignment opportunities, including owning nonconformances and CAPAs.
• Documents and maintains complaint coding and reportability decisions to Global Regulatory Authorities. Coding and reporting decisions are documented and maintained in the Complaint Coding and Reportability Matrix and utilized as guidance by the Post-Market QA Team for complaints investigations.
• In aggregate, analyzes and interprets complaint data and prepares responses to external requests (i.e. regulatory agency requests) or internal requests (i.e. regulatory submission support, R&D product development or quality investigation support). Analyze and present complaint trend data at Management review, recommend areas for additional review or investigation.
• Performs imaging reviews with clinicians, determines root cause of the reported events, and writes a final report in order to satisfy regulatory investigational requirements.
• Other duties assigned by leadership

What you’ll need (Required Qualifications):

• Bachelor's degree in nursing, scientific, or quality related field plus a minimum of 10 years of relevant experience; or a Master’s degree in nursing, scientific, or quality related field plus a minimum of 8 years of relevant experience.
• Medical device industry, quality systems, or hospital/clinical experience (e.g. cath lab, cardiac care, ICU, OR, or cardiovascular/endovascular interventions).  Combination of nursing, quality and/or medical device industry experience is a strong plus.
• Supervisory or people leadership experience.
• Registered nurse with current state license in good standing
   

What else we look for (Preferred Qualifications):

• Demonstrated ability to lead and manage a team.
• Proven experience with complaint handling and managing MDR (Medical Device Reporting).
• Extensive experience with CAPAs, NCRs, and Failure Analysis.
• Medical Device (cardiovascular, endovascular, or other critical care/surgical products)
• Strong understanding of risk management principles and practices.
• Proficiency in interpreting and analyzing clinical complaint data.
• Strong analytical skills with the ability to identify trends and conduct root ca