Job Description

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 4,000 liver transplant operations globally. Position Summary As part of our ongoing expansion in North America, we 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.

Major Responsibilities:

• Manage and maintain all controlled company documents, including processing and recording revisions.
• Verify and ensure the accuracy and quality of documents.
• Update and control procedure documents and forms.
• Create and manage document hierarchy and process systems.
• Train employees in the use of controlled documents.
• Ensure all documents meet set standards in terms of quality and compliance.
• Coordinate 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.
• Implement and maintain document control processes and procedures.
• Develop and maintain a comprehensive filing system and computer database for all documents to be retained in the document control center.
• Manage the flow of documentation within the organization.
• Maintain confidentiality around sensitive documentation.
• Prepare reports and audits to help identify document inconsistencies.
• Ensure all documents are up-to-date and accurately reflect current policies and procedures.
• Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies.

Requirements

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.

3 years of experience.

Ability to travel 10% of the time.

Benefits

WHAT WE OFFER:

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.

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