Device and Product Assurance Manager
|Contact Name:||John Reid|
My client a leading Multinational Healthcare Manufacturing company now require a Device and Product Assurance Manager to join their expanding team.
The Device and Product Assurance Manager is responsible for providing technical leadership to the group on engineering verification, design verification, device functional stability, defect management, biological evaluation, extractables/ leachables, management of laboratories at 2 sites, specifications & methods development, transport & shipping studies, development of device control strategy.
This is a permanent role based in Dublin and it comes with a very good salary with good benefits.
Responsibilities of a Device and Product Assurance Manager
? Represent the device and product performance group on cross functional project teams, by taking responsibility and executing design control activities to support regulatory submissions and approvals on a range of device programs
? Responsible for compilation of the device analytical content of regulatory submissions and responses to support companies diverse portfolio including Biologics, Biosimilar, injectable and respiratory products
? Collaborates and maintains strong leadership links with the drug product analytical development project teams to ensure overall analytical approach to drug-delivery system development is aligned
? 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 ensure build and develop robust project plans ensuring that all analytical 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
? Well-developed communication skills to lead or facilitate effective discussions. Is able to communicate technical and/or project information to key stakeholders.
? Ensures all activities within team are conducted and executed to the appropriate quality standards within the Quality Management system
Requirements of a Device and Product Assurance Manager
? Degree in Science/Engineering with several years' experience of industry experience
? Previous experience of working in an analytical role in a regulated and GMP environment on Biologic, Biosimilar or Injectable products pre and post submission is essential
? Previous experience in compiling analytical sections of NDA, ANDAs, BLAs is desirable
? 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 has the ability to work as part of a flexible, dynamic team whilst taking responsibility for individual tasks.
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The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
For more information please contact John at The RFT Group / www.rftgroup.ie / 01 2302400 or click apply below