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.

POSITION SUMMARY

OrganOx are seeking a meticulous and organized Document Control Specialist to manage our documents to ensure compliance with company policies, industry standards, and legal requirements. The ideal candidate will have excellent attention to detail, strong organizational skills, and experience with document management software. This role is crucial for ensuring that all company documents are accurate, accessible, and compliant with regulatory standards.
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..
This is an on-site role in Oxford with flexibility and will include up to 10% travel.

SKILLS & EXPERIENCE

• Demonstrable experience in a similar role, preferably within the medical technology / medical device industry.
• Experience in an FDA regulated environment a plus.
• Subject Matter Expert with document management software, preferably Master Control or Trackwise.
• Proficiency in Microsoft Office Suite and other relevant software.
• Knowledge of industry standards and regulatory requirements.
• Familiarity with quality management systems.
• Strong organizational and multitasking skills.
• Excellent attention to detail and a “do it right the first time” attitude.
• Ability to prioritize and manage time effectively.
• Strong communication skills, both written and verbal.
• Ability to thrive in a fast-paced environment, adapt to change, and comfortably navigate ambiguity with confidence.

QUALIFICATIONS

• Bachelor’s degree in a scientific or technical discipline, or equivalent work experience.

• Under direction from the Manager QMS and Document Services, the Document Control Specialist will be responsible for:
• Managing and maintain all controlled company documents, including processing and recording revisions.
• Verifying and ensure the accuracy and quality of documents.
• Updating and control procedure documents and forms.
• Creating and manage document hierarchy and process systems.
• Adhering to the letter and spirit of OrganOx’s Code of Conduct and all other company policies
• Training employees in the use of controlled documents.
• Ensuring all documents meet set standards in terms of quality and compliance.
• Coordinating activities related to the document control procedure, including the distribution of documents and ensuring access. Input document data into standard registers ensuring that the information is accurate and up to date.
• Implementing and maintain document control processes and procedures.
• Developing and maintain a comprehensive filing system and computer database for all documents to be retained in the document control center.
• Managing the flow of documentation within the organization.
• Maintaining confidentiality around sensitive documentation.
• Preparing reports and audits to help identify document inconsistencies.
• Ensuring all documents are up-to-date and accurately reflect current policies and procedures.
• Adhering to the letter and spirit of OrganOx’s Code of Conduct and all other company policies.