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Device Analytical Manager
Device Analytical Manager - Global Pharmaceutical Business
Medical Device Sector - R&D
About Our Client
Our client is a global pharmaceutical company with a major interest in medical devices.
The successful candidate will join the Global Device Development (GDD) within R&D as Device Analytical Manager within the Device and Product Performance group.
- Lead team to set up a new device testing laboratory in Dublin. Set up will include facility and utility preparation, equipment qualification of off the shelf and Bespoke device testing equipment, development of test methods and training of analysts.
- Work with the project teams within Global Device Development to design and execute protocols that meet regulatory requirements to support Engineering and Design Verification, device stability, Extractables and Leachables, Biological Evaluation and Device control strategy.
- Develop Device verification test plans in line with ISO 11608 and ISO 11040 and other relevant regulatory guidelines. Participate in design reviews throughout the device product lifecycle by identifying and addressing any analytical gaps and providing technical expertise to the project lead.
- 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
- Represent the device and product performance group on cross functional teams both internally within GDD and externally to support regulatory submissions and approvals on a range of device programs.
- Vendor management. Work with external laboratories to ensure study protocols are executed in line with GDD requirements including quality and regulatory requirements.
The Successful Applicant
The ideal candidate will be a qualified, experienced pharmaceutical professional with a proven track record of success within a fast paced environment.
Degree in Science/Engineering with a minimum of 5 years' experience
Previous experience of working within a medical device environment.
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.
What's on Offer