Spectrum Vascular is an innovative medical device company focused on vascular access and medication management. Our mission is to improve the lives of patients worldwide by providing caregivers with high quality, innovative products with exceptional customer service. We are a company that was formed through the acquisition of a portfolio of trusted products that have been widely used by customers for decades. Innovation has been a core strategic pillar throughout our history and many of our products have been designed to deliver antimicrobial and antithrombogenic protection or to support certain patient populations such as those who are critically ill and pediatrics. This role represents a unique opportunity to join a dynamic and growing team with established products and an entrepreneurial mindset.

The Complaint Specialist is responsible for receiving, documenting, investigating, and resolving product complaints in accordance with company policies, regulatory requirements, and industry standards. This role plays a critical part in ensuring compliance with applicable regulations, including the US FDA QMSR, ISO 13485, EU MDR, and other global requirements. The Complaint Specialist works cross- functionally with Quality, Regulatory, Engineering, and CMO’s to ensure timely and thorough complaint resolution and continuous product improvement.

Role Responsibility:

· Ensures the processing of complaints in a timely manner by coordinating and prioritizing complaint investigations.

· Communicates with health care providers (HCP), HCP staff and/or patient to acquire relevant complaint information.

· Responsible for facilitating the complaints process by receiving, reviewing and entering product complaint information into the complaints database.

· Participates in root cause investigations in collaboration with cross-functional teams, including Quality, Engineering, and CMO’s.

· Coordinates and facilitates meetings to discuss complaints, prepares meeting minutes, and follows up on action items.

· Contributes to the development and improvement of complaint handling procedures, work instructions, and forms.

· Escalates issues to management and supports CAPA activities when necessary.

· Provides customer communication and follow-up regarding complaint resolution status, as appropriate.

· Evaluates complaint information and determines appropriate regulatory reporting requirements.

· Prepares and submits reports to US FDA and other regulatory agencies within required timeframes.

· Responds to inquiries from customers, regulators, and others as needed.

· Prepares and analyzes trend reports on a monthly, annual, and ad hoc basis.

· Assists with Post-Market Surveillance (PMS) activities as needed.

· Maintains confidentiality and integrity of complaint files and records.

· Other duties as assigned

Skills and Competencies:

· Interpersonal Effectiveness: Actively seeks to understand perspectives and interpersonal needs and expectations of others at all levels, builds self-awareness, flexes personal style appropriately, and works through conflicts constructively and appropriately

· Communication: Effectively uses all mediums of communication as appropriate, presents well to groups, actively listens, and continuously identifies opportunities to build communication skills

· Collaboration & Teamwork: Actively works together with formal and informal team members to build relationships and achieve team goals

· Prioritization: Effectively prioritizes work to ensure timely completion of work within scope

· Technical Expertise: Continuously builds functional and technical expertise, and pro-actively applies that technical expertise in progressively broader scope

· Continuous Improvement: Learns and uses best practices tools and methodologies to assess, identify, and executes on opportunities to improve; Focus on learning and building new capabilities into self

· Problem Solving & Problem Prevention: Learns and uses strong problem-solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention

· Accountability: Focuses on results, takes initiative without direction, takes ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility