Expiry Date: 21-09-2021
Category Regulatory Affairs
Job Type: Full Time
Windsor and Maidenhead
Device Operations Lead - Contract - Berkshire & Remote
As part of Device Operations and Usability team, this global role is focused on the human factors activities for the clients drug delivery technologies and other medical devices for clients chemical and biological medicines including their packaging and labeling needs. This work will be performed in collaboration with the cross-functional technical program teams that ensure the design, development, industrialization, and life cycle management of medical device programs to meet the needs of internal stakeholders and ultimately patients. Importantly, this role will work across the portfolio of Device Packaging & Wearable Technologies programs.
This role is expected to take leadership duties with respect to human factors activities in managing the interface with external partners, assessing and controlling the budgetary and timeline implications for human factors studies, and ensuring compliance with the medical device Quality Management System as well as Good Manufacturing Practice (e.g. ISO 13485, 21 CFR820, Medical Device Regulations).
This position reports to Head of Device Operations and Usability.
• Operational planning, execution, and reporting of Human Factors studies to industry and international regulatory agency standards and expectations
• Preparing and communicating material for submission to regulatory authorities, principally in the context of human factors studies
• Generation of supportive materials, including provisional artwork and physical documents to support the conduct of Human Factors usability studies
• Project management, creation and maintenance of packaging and labeling content in collaboration with secondary packaging defining the visual identity (design, text, technical elements) to support marketed medical devices (e.g. user manual, label text, carton text, instructions for use) and drug product programs (e.g. pharmacy manual)
• Project management, creation and maintenance of packaging and labeling content in collaboration with secondary packaging defining the visual identity (design, text, technical elements) to support medical devices and drug product programs in development (as above)
• Support regulatory/technical aspects of packaging and labeling requirements and specifications, e.g. adhesion testing/requirements, material and printing process requirements, legibility/readability testing, cleaning testing
• Ensuring the appropriate translation of packaging and labeling to support the above activities. This includes physical packaging and labeling (e.g. instructions for use) as well as digital items (e.g. graphical user interface)
• Coordination of activities with artwork providers/suppliers, the management of artwork versions within clients systems and visual identity developed by secondary packaging. This includes appropriate budget management, quotations, and negotiations with suppliers.
• Use of appropriate systems (Global Master Packaging System (GMPS)) to manage packaging and labeling materials
• Provision of technical input to Regulatory Affairs labeling activities
• Operational support for planning, execution, and reporting of Shipping Validation studies to industry and international regulatory agency standards and expectations.
• Proven track record in project management and working in cross-functional teams
• Pharmaceutical business experience and familiarity with competitive landscape of devices and pharmaceuticals, drug development process, health economics and health outcomes
• Experience in generating technical documentation
• Knowledge of Good Manufacturing Practice (e.g. ISO 13485, 21 CFR820, Medical Device Regulations) and evolving regulatory expectations in the field of medical devices and mobile health, including human factors engineering
• High level of expertise in Human Factors/Usability engineering per FDA/IEC 62366 and AAMI standards with an expectation to continual maintenance and awareness of current best practices and expectations in Human Factors/Usability through appropriate external training courses, conferences etc.
• Experience in medical device risk management activities as relates to medical device packaging and labeling
• Experience in managing and negotiating project budgets and quotes
• Experience in graphical design and related software tools (Adobe Illustrator, or comparable)
• Project management skills in planning, tracking, controlling, anticipating
• HS&E processes and procedures.
If this sounds like you please get in contact asap.
To apply for this role, please contact me, the Clinical & Medical Hiring Lead, asking for Roland Schnapka, on +44 (0)207 801 3387 or send a full CV to firstname.lastname@example.org. Alternatively, please press the red “Apply for position” button and follow the registration process.
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