Complaints Manager

ABOUT ORGANOX:

OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company’s first product, the OrganOx metra® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 4,000 liver transplant operations globally, optimizing the use of donated organs by enabling assessment of the quality of livers as well as longer preservation durations.  As part of our ongoing expansion, we seek a Complaints to join our team.

POSITION DESCRIPTION:

The position of Complaints Manager will ensure compliance of the Complaints System to internal requirements and domestic and international regulations.This includes the managementof regulatory activities related to complaints reporting, planning and executing field corrective actions, as well as the quality systems processes and procedures, training materials, and controls that support execution of medical device reporting and field corrective actions in conformance to established agency regulations. This position will be located in the OrganOx US office located in Madison, NJ.

This role will report directly to the Director, Complaints Management located in the US and will also work closely with the Global Complaints Manager located in the UK.  

Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally inclusive, and the person will be expected to complete tasks reasonably requested by the Director, Complaints Management.

This is an onsite, in-office position in Madison NJ.

KEY RESPONSIBILITIES

Under direction from the Director Complaints, the Complaints Manager will be responsible for:

1.      Leadership and Strategic Vision

Establish a forward-thinking vision for complaint handling, aligning team objectives with overall company strategy and industry best practice.

Set clear expectations, performance goals and KPI’s for the team, ensuring alignment with operational targets and fostering an inclusive high-performance culture.

Lead by example, promoting inclusive teamwork, transparency and a customer centric approach for internal and external stakeholders.

Mentor and coach team members, developing their skills and fostering leadership potential within the team.

2.      Data Collection and Data Entry

Lead staff responsible for initiating complaints and ensuring all required information is added to complaint files in an accurate and timely manner.

Communicate with customers and field representatives in a professional manner to gather additional complaint information as warranted.

Support service and repair events including evaluation of intake information, review of repair activities to assess whether a complaint is warranted, and facilitation of device returns.

Ensure complaints are prioritized based on patient, product, and compliance risk.

3.      Adverse Event Reporting

Ensure Adverse Event Reporting regulatory guidance documents are available prior to product launch within all jurisdictions and applicable Post Market Surveillance activities are captured.

Complete reportability assessments and routing for approvals in a timely manner.

Submit adverse event/vigilance reports to TGA, MHRA, FDA, Health Canada, notified bodies, and competent authorities as appropriate.

4.      Investigation and Root Cause Analysis

Ensure completion of technical evaluations and investigational tasks required for complaints.

Accurately assess risk and escalating high risk incidents to vigilance.

In conjunction with Quality Engineering, complete complaint investigation reports using concise and grammatically correct English (appropriate for regulatory review).

Close complaints in a timely and accurate manner.

5.      Compliance and Continuous Improvement

Lead continuous improvements and ongoing compliance of the Complaints, Post Market Surveillance, Regulatory Reporting and Risk Management Systems.

Support internal and external audits.

Ensure assigned complaint metrics are achieved (e.g., achieve target times for complaint reporting or complaint completion).

Assist with training staff to ensure compliance to Complaints/Post Market Surveillance requirements.

Prepare reports on complaint trending, complaint metrics, post market surveillance activities, Periodic Safety Reports etc.

Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies.

·Other duties as assigned.

6.      Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies.

SKILLS AND EXPERIENCE:

Working knowledge of FDA processes for medical device compliance.

Knowledge of EU MDD / MDR, MDSAP, CMDR, PMDA/PAL, APAC Country requirements, LATAM.

Root cause analysis techniques.

Ability to write clear investigational plans and reports.

Strong understanding of GMP compliance requirements in Quality Control.

Strong understanding of handling and decontamination of medical devices and equipment.

Ability to collect, organize and analyze information to identify product and quality problems.

Working knowledge of material, process, and product specifications, and inspection techniques.

Experience in cross-functional collaboration with Manufacturing, Supply Chain, R&D, and Servicing departments.

Computer proficiency in MS Office (i.e., Word, Excel, PowerPoint)

Excellent verbal and technical writing skills.

Ability to work independently.

At OrganOx, we value innovation, evidence, integrity, teamwork, respect, and passion. We offer competitive compensation and comprehensive benefits, including healthcare and retirement plans. We support work-life balance and provide opportunities for ongoing professional development.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.