Senior Technical Manager
1 month ago
We are seeking a highly skilled Senior Technical Manager to lead our device development efforts. As a key member of our team, you will be responsible for ensuring the successful development and qualification of our drug device combination products.
Key Responsibilities- Act as the subject matter expert for device-related topics, providing technical guidance and support to cross-functional teams.
- Lead the development of technical deliverables, ensuring timely delivery of GMP-compliant product batches.
- Manage the creation and review of device design documents, including the Design History File and General Safety Performance Requirements.
- Ensure successful Human Factor studies for each device presentation.
- Develop and maintain strong relationships with Contract Manufacturing Organizations (CMOs).
- Oversee the qualification process to ensure commercial launch readiness.
- Review and approve batch documentation, validation activities, risk/gap analysis, protocols, and reports.
- Manage stability plans and review data to support product shelf-life and extreme conditions.
- Support technical decision-making, trend analysis, and root cause investigations.
- Contribute to quality, supply, innovation, and cost aspects for drug device combinations.
- Support regulatory submissions and responses to Health Authority questions and requests.
- Collaborate with internal stakeholders to support drug product production, clinical development, and product supply/transport activities.
- Bachelor of Science degree in Biotechnology or relevant discipline with a minimum of 10 years of pharmaceutical industry experience.
- Proven track record of partnering internally and externally to deliver drug device combination product milestones on-time and right first time.
- Experience with US and EU regulatory filings for clinical trial and/or marketing applications.
- Demonstrated leadership to drive results that achieve the company's goals.
- A learning environment that fosters growth and innovation.
- The opportunity to contribute to groundbreaking projects that transform global healthcare.
- A flexible work arrangement that balances work and life.
- A clear path for career progression and professional development.
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Senior Tax Manager
4 weeks ago
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Senior Tax Manager
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom Hays Senior Finance Full timeHays Senior Finance is recruiting a Senior Manager for one of the UK's leading integrated wealth management and professional services group.Our client has an exceptional track record of growth and innovation, driven by their core values and the best people they employ. The Cambridge office is on an ambitious growth journey, requiring a driven and ambitious...
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Senior Tax Manager
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom Hays Senior Finance Full timeAbout the RoleHays Senior Finance is recruiting a Senior Tax Manager for one of the UK's leading integrated wealth management and professional services group. Our client has an exceptional track record of growth and innovation and is looking for a driven and ambitious Tax Senior Manager to join their dynamic team in Cambridge.Key ResponsibilitiesYou will be...
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Senior Tax Manager
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Senior Technical Manager
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Senior Technical Marketing Manager
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Senior Technical Manager
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Cambridge, Cambridgeshire, United Kingdom Hays Senior Finance Full timeHays is a leading UK wealth management and professionals' services group, renowned for its growth, innovation, and commitment to excellence.Job OverviewWe are seeking a highly skilled Senior Tax Manager or Associate Director to join our dynamic team in Cambridge. This individual will play a crucial role in driving business development, expanding existing...
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Senior Manager Technical Lead
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Senior Technical Lead
2 weeks ago
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Senior Technical Operations Manager
5 days ago
Cambridge, Cambridgeshire, United Kingdom EA First Compass House Full timeJob OverviewWe are seeking a highly skilled and experienced Senior Technical Operations Manager to join our team in Cambridge. As a key member of our IT department, you will be responsible for the overall strategy and management of our IT systems.
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Senior Technical Architect
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom arm limited Full timeJob Title: Senior Technical ArchitectJob Summary: We are seeking a highly skilled Senior Technical Architect to join our Central Technology Systems Group. As a Senior Technical Architect, you will be responsible for shaping the next generation of connected embedded devices and solutions.Responsibilities:Develop the technology roadmap in collaboration with...
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Senior Technical Product Manager
1 month ago
Cambridge, Cambridgeshire, United Kingdom Evi Technologies Limited - C67 Full timeAbout the RoleWe are seeking a Senior Technical Product Manager to join our team at Evi Technologies Limited - C67. As a key member of our product development team, you will be responsible for building and iterating on core experiences that help customers achieve their goals.Key ResponsibilitiesDevelop and execute comprehensive product strategies aligned...
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Technical Futures Lead
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Technical Futures Ltd Full timeCompany OverviewA deep-tech start-up in the Sustainability arena is looking for a highly skilled Technical Project Manager to join their team. With a strong coaching/mentoring background and experience in successful project delivery, you will oversee the delivery of customer projects and ensure they are completed on time and to budget.SalaryA generous...
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Senior Quantity Surveyor
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Senior Technical Support Engineer
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