Complaints Specialist Hybrid - Warren NJ

Spectrum Vascular; New Jersey; On-site; USD 50,000 - 75,000; Full time

Job summary

Spectrum Vascular is seeking a Complaint Specialist to receive, document, investigate, and resolve product complaints in line with FDA QMSR, ISO 13485, and MDR requirements. You will collaborate with Quality, Regulatory, Engineering, and CMO teams to ensure timely resolutions and continuous product improvement.

The ideal candidate has a Bachelor's degree with at least 3 years of medical device complaint handling experience, strong regulatory knowledge, and meticulous attention to detail.

Qualifications

• Bachelor’s degree in a technical, scientific, or business-related discipline preferred.
• 3 years related work experience as a complaint handler in the medical device industry, performing all duties described above.
• Knowledge of medical terms and Medical Device Reporting regulations (MDR).
• Exceptional organizational skills and attention to detail.
• Able to perform job function with minimal supervision and work independently.

Responsibilities

• Receives, documents, investigates, and resolves product complaints in accordance with company policies and regulatory requirements.
• Coordinates complaint investigations and communicates with health care providers and patients to obtain relevant information.
• Enters product complaint information into the complaints database and contributes to root cause investigations with cross-functional teams.
• Supports CAPA activities and assists with development and improvement of complaint handling procedures and forms.
• Prepares and submits reports to US FDA and other regulatory agencies within required timeframes.
• Maintains confidentiality and integrity of complaint files and records.

Skills

Complaint handling

Regulatory reporting

Cross-functional teamwork

Communication

Quality systems

CAPA

Trend analysis

Documentation

Root cause

Process improvement

Education

Bachelor’s degree

3 years experience in medical device complaints

Regulatory knowledge (RDR/ MDR)

Attention to detail

Job description

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, EUMDR, 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 andprioritizing complaint investigations.
• Communicates with health care providers (HCP), HCP staff and/or patient toacquire relevant complaint information.
• Responsible for facilitating the complaints process by receiving, reviewing andentering product complaint information into the complaints database.
• Participates in root cause investigations in collaboration with cross-functionalteams, including Quality, Engineering, and CMO’s.
• Coordinates and facilitates meetings to discuss complaints, prepares meetingminutes, and follows up on action items.
• Contributes to the development and improvement of complaint handlingprocedures, work instructions, and forms.
• Escalates issues to management and supports CAPA activities when necessary.
• Provides customer communication and follow-up regarding complaint resolutionstatus, as appropriate.
• Evaluates complaint information and determines appropriate regulatory reportingrequirements.
• Prepares and submits reports to US FDA and other regulatory agencies withinrequired 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 andinterpersonal 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 informalteam members to build relationships and achieve team goals
• Prioritization: Effectively prioritizes work to ensure timely completion of workwithin scope
• Technical Expertise: Continuously builds functional and technical expertise, andpro-actively applies that technical expertise in progressively broader scope
• Continuous Improvement: Learns and uses best practices tools and methodology to assess, identify, and executes on opportunities to improve; Focus on learningand building new capabilities into self
• Problem Solving & Problem Prevention: Learns and uses strong problem-solvingmethodologies and tools, focuses on root cause analysis, and shows orientationtowards problem prevention
• Accountability: Focuses on results, takes initiative without direction, takesownership for all work within scope, builds relationships and works acrossdepartments, functions, or areas of responsibility

Qualifications (Education & Experience)

• Bachelor’s degree in technical, scientific, or business-related discipline preferred.
• 3 years related work experience as a complaint handler in the medical device industry, performing all duties described above.
• Knowledge of medical terms and Medical Device Reporting regulations
• Exceptional organizational skills and attention to detail.
• Able to perform job function with minimal supervision and work independently, taking initiative to make independent decisions, where appropriate.

Physical Demands (if any) as well as how much travel the job requires

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job:

• Work safely and follow all OSHA regulations and company safety policies and procedures.
• For all on-the-job injuries or accidents, must notify manager /supervisor immediately .
• Ability to regularly sit or stand for extended periods of time.

Other Disclosures

Spectrum Vascular is an Equal Opportunity / Aff…? We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. For certain roles at Spectrum Vascular, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. Consistent with Spectrum Vascular’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.