Regulatory Affairs Specialist

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 5,000 liver transplant operations globally. As part of our ongoing global expansion, we seek a motivated Regulatory Affairs Specialist to join our team.

Position Summary

The position of Regulatory Affairs Officer is responsible for performing regulatory administration and support activities for OrganOx Limited and will report directly to the Regulatory Affairs Manager.

This is a flexible on-site role in Oxford.

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 exhaustive.

Requirements

Major Responsibilities

Under direction from the Regulatory Affairs Manager and/or Global Labelling and Compliance Manager, the Regulatory Affairs Specialist will:

• Perform and/or coordinate regulatory documentation updates as requested by the Regulatory Affairs Manager to support the relevant department(s) in fulfilling regulatory requirements
• Under the instruction of the Regulatory Affairs Manager, perform administration and compilation of documentation needed for regulatory submissions
• Working with wider team members to gather required information for change submissions to the Notified Body
• Assist with submission of change requests to the Notified Body (NB), logging NB responses or approvals and assisting with any requests for further information.
• Assist the Regulatory Affairs Manager with maintenance and creation of product registrations and certifications
• Support the Regulatory Affairs Manager with data gathering and analysis for trend reporting into Post Market Surveillance activities
• Work with the Global Labelling and Compliance Manager and Regulatory Affairs Manager to maintain regulatory information within OrganOx’s Regulatory Information Management Software, RIMSYS
• Assist with training for new and existing employees on the RIMSYS Regulatory Information Management Platform
• Assist the Global Labelling and Compliance Manager to maintain Technical File documentation
• Assist the Global Labelling and Compliance Manager with maintenance and control of product labelling
• Assist during notified body audits
• Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies

Skills & Experience

• High level of attention to detail (essential)
• Good scientific writing skills (essential)
• Proficient in Microsoft Word and Excel (essential)
• Excellent organization skills (essential)
• Experience working in medical devices in a Quality or Regulatory function (essential)
• Experience of administration of documentation for regulatory submissions (ideally)
• Experience in maintenance of medical device registrations EU/UK (ideally)
• Experience working within ISO 13485:2016 quality management system (essential)
• The ability to work within a fast paced, changing environment and comfortable dealing with ambiguity

Qualifications

• A graduate degree is preferred but not essential
• A minimum of two years’ experience in regulatory affairs or quality within the medical device industry

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.

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, 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.