Document Control Specialist – IVD

Job Title: Document Control Specialist – IVD / Medical Devices

A career opportunity has arisen for a Document Control Specialist – IVD / Medical Devices to support the quality assurance team at a ground-breaking medical diagnostics organisation.

Our client is a well-funded and trail-blazing MedTech company with a disruptive diagnostics platform, providing fast and insightful near-patient analysis for a range of unmet clinical needs.

• Manage Controlled Documentation: Ensure compliance with company policies, procedures, and regulatory guidelines.
• Support Quality Assurance Team: Assist in ensuring documents are prepared, reviewed, updated, and distributed or stored within agreed timelines.
• Maintain Quality Management System: Ensure upkeep of the Quality Management System (QMS).
• Organise Document Control Database: Maintain and organise the document control database, ensuring documents are accurate, up-to-date, and easily accessible.
• Comply with Document Control Protocols: Identify and action areas of improvement, ensuring strict adherence to protocols.
• Deliver Training and Support: Provide training and support to colleagues for QA and document control activities.
• Point of Contact: Act as the point of contact for external stakeholders in relation to document control activities.
• Ensure Regulatory Compliance: Ensure documentation is organised and stored in compliance with medical device regulations e.g. ISO 13485 and 21 CFR Part 820.

• Prior Experience: Prior experience working with controlled documents from within a medical devices, diagnostics, or biotechnology organisation.
• Medical Device Regulations: A demonstrable understanding of medical device regulations and requirements e.g. ISO 13485 and 21 CFR Part 820.
• IT Skills: Strong IT skills, with a proficiency using Microsoft Office and similar software packages.
• eDMS/eQMS Experience: Experience with an electronic Document Management System (eDMS) and/or electronic Quality Management System (eQMS) would be highly advantageous.
• Attention to Detail: A keen eye for detail to be able to identify documentation abnormalities and take steps to address these.
• Communication Skills: Excellent communication skills and a personable nature to support relationship building with both internal and external stakeholders.
• Teamwork: Ability to work both independently and within the larger organisation team to ensure the smooth running of documentation activities.
• Qualifications: A degree (or equivalent working experience) in a scientific discipline such as Biology, Molecular Biology, Chemistry, Biotechnology, or a related area. In the absence of a degree, A-Levels or equivalent will be considered.