As a specialist in the field of medical device or combination product development, you will be responsible for ensuring that projects, primarily injection device development projects, are delivered according to best practice. You will have state-of-the-art knowledge of the regulations, directives, guidelines and standards relevant to the development of medical devices and combination products.
You will lead project reviews in order ensure that all of the essential development activities have been properly identified, correctly performed and appropriately documented. Where gaps are identified, you will plan, direct and deliver the remediation activities to close those gaps, building and leading a project team as required. As a subject matter expert you will also play a leading role in the continuous improvement of departmental procedures and ways of working.
- Conduct comprehensive reviews of injection device development projects and the associated Design History Files in order to identify gaps against the regulatory requirements and Teva’s Quality Management System.
- Where action is required, plan the remediation activities, identifying the time and resources required.
- o In particular, safety risk management activities will be prioritised in order to ensure that the devices developed are robust, safe and effective.
- Assemble and lead project teams from within the Steriles Device Team and, if required, from external suppliers, to deliver the remediation activities.
- o Activities are likely to vary significantly between projects, from closing "documentation gaps" to identifying and implementing design changes.
- Play a leading role in the continuous improvement of departmental practises:
- o Support development of Standard Operating Procedures, guidelines and templates.
- o Coaching and mentoring of team members.
- Will travel globally as required to support the projects, up to 25% of time out of the office. Travel might include visiting suppliers’ facilities or Teva manufacturing sites.
- Interfaces with numerous other business units, including legal, commercial, drug development, operations regulatory and procurement.
- In situations where remediation activities are contracted out to third parties, will be responsible for interfacing with these external suppliers as well as assessing and approving their output.
- Reporting to the Head of Remediation, who reports to the Head of Steriles Device Team. The Steriles Device Technology is part of the Global R&D Innovation Technology business unit.
- Graduate in Engineering, Scientific or other Technical discipline.
- Must have previous experience in working with medical device or combination products development, in particular the application of Design Controls and medical device Risk Management. Preferably experienced in drug delivery device development, in particular, injection devices.
- Experience of medical device, combination/medicinal product regulatory requirements for global commercialisation.
- Technical knowledge and ability to understand and to resolve typical problems encountered with developing mechanical systems and manufacturing processes.
- Competent in the use of statistical methods, for example for the determination of design input requirements, verification and validation testing.
- Mentoring and coaching skills.
- Pragmatic approach to problem solving and balancing conflicting requirements.
- Excellent verbal and written communication.
- Confident in own judgement. Prepared to take difficult decisions and able to persuade others. Where appropriate, willing to challenge the status quo.
- Cooperative and helpful attitude towards colleagues and customers. Aptitude for working in a team environment.
- Enjoys challenge. Adapts to change, coping with risk and uncertainty, while remaining positive. Willing to operate outside remit to meet deadlines when necessary.
- Medical Devices
- Problem Solving