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Details

Senior Manager Device and Product Performance


Reference:SCA006643 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:Fixed Term ContractSalary: Not Disclosed

Senior Manager, Device and Product Performance


Our Dublin based client are currently recruiting for a Senior Manager for their Device and Product Performance group. The ideal candidate will have experience working with combination products in a GMP environment.


Responsibilites
• Responsible for managing partnership activities with external company to support the development of a bespoke respiratory device to enable commercial and launch readiness


• Responsible for providing technical leadership to support the development of a respiratory combination product (device and drug product)


• Including activities such as comparator analysis, device analytical testing to support device design, metrology, engineering verification, design verification, device functional stability, defect management, biological evaluation, extractable / leachable, specifications & method development, transport & shipping studies and development of device control strategy.


• Development of the device design requirements to ensure that the device performs as intended for the patient population and meets the required regulatory requirements for combination products


• Responsible for ensuring that device requirements are met by performing robust device and product characterization throughout the design development program


• Responsible for technical interface between drug product and device teams during combination product development. Provide technical support to manufacturing sites during device assembly process development by designing experiments, defining device controls and identifying sampling and testing requirements


• Well-developed communication skills to lead or facilitate effective discussions


• Able to communicate technical and/or project information to key stakeholders


• Responsible for critical review of the device analytical content of existing project including identification of any regulatory gaps and development of remediation plan


• Review and interpretation of analytical data in line with study and protocol objectives


• Trending and statistical analysis of analytical data and compilation of technical reports to support design and development lifecycle


• Work with the program lead to build and develop robust project plans ensuring that all device development activities are included and linked to critical project milestones


• Responsible for compilation and review/approval of device test protocols, reports and specifications in line with global regulatory requirements, guidance’s and the latest regulatory and industry thinking


• Vendor management. Identify CROs capable of performing device testing to meet EU, US and ROW regulatory requirements


• Work with the Quality and legal groups to get CROs approved for testing.


• Establish relationship and manage timelines and contracts to support project requirements


• Ensures all analytical activities are conducted and executed to the appropriate quality standards within the Quality Management system


Requirements


• Qualified, experienced pharmaceutical professional with a proven track record of success, a positive attitude and who wants to progress in a fast-paced environment


• Degree (or equivalent) in Science/Engineering with demonstrable relevant experience


• Previous experience of working in an analytical role in a regulated and GMP environment on respiratory products


• Previous experience in compiling analytical sections of regulatory submissions is desirable


• An understanding of Design Control requirements and working within a GMP controlled regulatory environment. A working knowledge of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements would be an advantage


• Highly driven and motivated person who can work as part of a flexible, dynamic team whilst taking responsibility for individual tasks

• Highly innovative and well organised, having excellent planning and communication skills and able to operate across all site teams


• The ability to work under pressure and have a proven track record of problem solving and effective time management

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252