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 worldwide. The company’s first product, the OrganOx metra® normothermic machine perfusion (NMP) system for liver transplantation, has supported more than 5,000 liver transplant operations globally.
Position Summary
OrganOx is seeking a meticulous and organized Document Control Specialist to manage our documents and ensure compliance with company policies, industry standards, and legal requirements. This is an on‑site role in Oxford with flexibility and up to 10% travel. The role is crucial for ensuring that all company documents are accurate, accessible, and compliant with regulatory standards.
Major Responsibilities
* Managing and maintaining all controlled company documents, including processing and recording revisions.
* Verifying and ensuring the accuracy and quality of documents.
* Updating and controlling procedure documents and forms.
* Creating and managing document hierarchy and process systems.
* Adhering to 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 distribution of documents and ensuring access. Input document data into standard registers ensuring the information is accurate and up to date.
* Implementing and maintaining document control processes and procedures.
* Developing and maintaining a comprehensive filing system and computer database for all documents 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.
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.
Benefits
OrganOx offers competitive compensation and comprehensive benefits, including healthcare and retirement plans. We support work‑life balance and provide opportunities for ongoing professional development.
Equal Opportunity Statement
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex, sexual orientation, or any other characteristic protected by law.
Location: Oxford, England, United Kingdom
Seniority level
Entry level
Employment type
Full‑time
Job function
Administrative
Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr