Quality & R&D Documentation Coordinator

Role Purpose

This is an opportunity to play a central role in keeping Ostoform’s quality, R&D and regulatory documentation accurate, complete and ready when it is needed. As Quality & R&D Documentation Coordinator, you will prepare, review, coordinate and maintain quality-system and regulatory documentation throughout the medical-device product lifecycle. You will administer and track documentation supporting product realisation, change control, complaint handling and controlled regulatory updates in accordance with ISO 13485, applicable regulatory requirements and company procedures.

Working closely with Quality, Regulatory, R&D, Operations and Supply Chain, you will help ensure that documentation is accurate, complete, traceable, approved and available within required timelines. You will also coordinate and support the creation of documentation for management assessments and approvals, giving you visibility across a growing medical-device business and its product-development activities.

Key Responsibilities

•  Prepare, compile and maintain product-realisation records in accordance with approved procedures, quality plans and applicable regulatory requirements.

•  Coordinate documentation for design and development activities, design transfer, purchasing controls, production readiness, verification, validation and product release, as applicable.

•  Liaise with Quality, Regulatory, R&D, Operations, Supply Chain and other functions to obtain timely inputs and resolve documentation gaps.

•  Coordinate quality-system, product, process, supplier, packaging, labelling and regulatory change requests from initiation through assessment, approval, implementation and closure.

•  Log, acknowledge and coordinate complaints in line with company procedures and applicable reporting timelines.

•  Coordinate controlled updates to technical documentation and regulatory records resulting from product, process, supplier, labelling or organisational changes.

•  Draft, format, review and route procedures, work instructions, forms, templates and records for approval in accordance with document-control requirements.

Essential Experience

•  Qualification in quality, regulatory affairs, science, product design/engineering, life sciences, business administration or a related discipline, or equivalent relevant documentation experience.

•  Working knowledge of ISO 13485 and good documentation practices.

•  Strong attention to detail, organisation and follow-through, with the ability to manage several controlled activities and deadlines.

•  Clear written and verbal communication skills and confidence working with cross-functional stakeholders.

•  Proficiency with Microsoft Office and electronic document-management or QMS systems.

Desirable Experience

•  Experience in the medical-device industry.

•  Experience with product-realisation records, engineering or quality change controls, complaint investigations, technical documentation or regulatory submissions.

•  Knowledge of risk management, corrective and preventive action, post-market surveillance and audit support.

•  Familiarity with applicable medical-device regulations in the markets served by the company.

•  Experience preparing, administering and maintaining controlled documentation in a regulated or quality-managed environment.

General Responsibilities

The post-holder must comply with all applicable company policies, QMS procedures, health and safety requirements, data-protection obligations and confidentiality requirements. Responsibilities may be reasonably amended to reflect business, regulatory or QMS needs, subject to appropriate communication and training.