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Endo

Technical Manager, Devices & Combination Products

Posted 18 Days Ago
Be an Early Applicant
Remote
Hiring Remotely in Ireland
Senior level
Remote
Hiring Remotely in Ireland
Senior level
The Technical Manager oversees technical activities for devices, ensures compliance with regulations, and collaborates across functions to meet product quality standards.
The summary above was generated by AI

Why Endo?

We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

Job Description Summary

The Technical Manager, Devices and Combination Products (DCP) is responsible for overseeing coordination and execution of technical activites related to devices and combination products, for both internaly and externally manufactured products, to support reliable product supply and quality.
The role is responsible for technical support and input into Design and Development (D&D) of new devices and combination products, and for support of in-line devices and combination products. The role will support maintenance of in-line product Design History Files (DHFs), including Design Change.
A key element of the role is to drive and lead DHF development, with the assistance of supporting functions.
This position is responsible for ensuring there are processes & procedures in place aligned to the global Design Controls policy, and that these are being followed to drive compliance with applicable regulations.
The role will work cross-functionally with R&D functions (regulatory affairs, formulation, clinical, medical affairs, and project management), as well as global manufacturing, supply chain, quality, and compliance to execute activities needed to ensure products meet patient needs and current device regulatory requirements.
The role requires working across different geographies and resulting time zones and therefore needs to be flexible in managing their time to work with the different sites.
‘Lives’ the Endo Core Values and Behaviors as they perform their duties in this role.

Job Description

Technical Manager, Devices and Combination Products (DCP)

Top Skills

Design Controls Policy
Design History Files

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