Adverse Event Reporting Specialist

ABOUT ORGANOX:

OrganOx has been transforming organ transplantation since 2008, leveraging groundbreaking normothermic machine perfusion technology in our flagship product, the OrganOx metra®. This technology helps preserve donor livers for up to 12 hours, in efforts to reduce organ discard rates and facilitating more successful transplants. We are an innovative, fast-paced global medical device company committed to improving transplantation outcomes. As part of our ongoing expansion in North America, we seek a motivated Adverse Event Reporting Specialist to join our team.

Position Summary

The position of Adverse Event Reporting Specialist will support the reporting obligations and management of communication between the manfacturer, importers and regulatory authorities for all medical device complaint activities. Duties will also include assistance of/or submission of medical device event reports in accordance with applicable laws and regulations. This role will report directly to the Complaints and Vigilance Manager, North America. 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 VP of Regulatory Affairs and Quality, North America.

This is a full time, in office role located at OrganOx’s US headquarters in Madison, NJ.  

Major Responsibilities

Under direction from the Complaints and Vigilance Manager, North America, the Adverse Event Reporting Specialist will be responsible for:

•         Initiating complaints and ensuring all required information are gathered and added to the complaints file in an accurate and timely manner.

•         Communicate with Customers and field representatives in a professional manner to gather complaint information.

•         Submitting adverse event reports to regulatory authorities.

•         Escalating adverse events per processes and/or procedures, when applicable.

•         Supporting service and repair events including evaluation of intake information and review of repair activities to assess whether a complaint is warranted.

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

•         Completing reportability assessment and route for approvals in a timely manner.

•         Facilitating complaint device returns investigations.

•         In conjunction with Engineering and/or Clinical, completing complaint investigation reports using concise and grammatically correct English (appropriate for regulatory review).

•         Assisting in closing complaints in a timely and accurate manner.

•         Supporting of ad hoc complaint metrics and data requests from key stakeholders such as regulatory, clinical, R&D, quality, and manufacturing.

•         Maintaining QA related logs and databases (e.g., Complaints, MDRs etc.)

•         Supporting regulatory submissions by providing Post Market Surveillance data trends.

•         Other duties as assigned.

•         This role may require travel up to 10% (including travel to the U.K.)

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

Skills and Experience

·       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.

Qualifications

The Adverse Event Reporting Specialist will have:

·       Minimum of 5 years related work experience is required.

·       Bachelor’s degree in engineering, science or nursing or the equivalent work experience.

·       Working knowledge of FDA processes for medical device compliance (e.g. 21 CFR 803 and 820)

·       Working knowledge of reporting adverse events to Health Canada (e.g. SOR/98-282).

·       Additional qualifications that are not required, but preferred:

o   Experience with either Master Control and/or Trackwise

o   CAPA process knowledge

o   Working knowledge of organ perfusion medical terms

o   Knowledge of adverse event/vigilance reporting to UK, EU, and Australia

A job description does not imply that the duties stated are the only ones to be performed by the job holder. Job holder will be required to follow any other job-related instruction as reasonably requested by their line manager or their designate.

WHAT WE OFFER:

The Pay Range for this position is $115,000 - $125,000 annually, with a 10% target annual bonus and benefits.

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, color, 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.