Company Overview
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 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. This is an on‑site role in Oxford with flexibility and will include up to 10% travel.
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 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 maintaining document control processes and procedures.
* Developing and maintaining 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.
Requirements
* Skills & Experience
* Demonstrable experience in a similar role, preferably within the medical technology / medical device industry.
* Experience in an FDA regulated environment is 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
At OrganOx, we value innovation, evidence, integrity, teamwork, respect, and passion. We offer competitive compensation and comprehensive benefits, including health care 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 age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex, sexual orientation, or any other characteristics protected by law.
Seniority level
* Associate
Employment type
* Full‑time
Job function
* Quality Assurance
Industries
* Non‑profit Organizations and Primary and Secondary Education
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