Job Description
An exciting opportunity has arisen for a Senior Manager in device development assurance to join our client, a specialty company based in Dublin.
This role will be a permanent position and it is an excellent time to join the company as they have several new and existing projects ongoing.
The successful candidate will have at least 8 years' experience working in a similar role in device development and manufacturing operations in a GMP environment. 3 of those years will be managing teams providing technical direction.
You will have experience in Medical Device, Pharma with device or combination device. A solid understanding of ISO13485 and GMP is essential. Experience in design control and design assurance is preferred. A degree in Biomedical, Mechanical or Science is required.
Responsibilities
* Lead a team of Device Development Engineers to ensure design assurance principles are effectively and consistently applied across the site and the Combination Product/Medical Device Development program teams.
* Drive continuous improvement projects and initiatives across the site.
* Support device development programs through the design and development lifecycle for Combination products and medical devices by compliance to design control requirements.
* Ensure Design History Files are established and maintained for development programs, for various program types.
* Liaise with Affiliate sites and Third Parties to ensure appropriate objective evidence and controls are established and maintained in line with program deliverables.
* Support the integration, and assess compliance with design assurance requirements, of acquired combination products and medical devices, into the product portfolio.
* Support Risk Management activities through the entire life cycle of medical devices and combination products through the implementation of ISO 14971:2019.
* Support maintenance of ISO 13485:2016 Quality Management System certification through involvement in Internal Audits, CAPA, Complaints, while ensuring relevant Regulatory requirements are adhered to.
* Participate in external audits. Establish best practice training to internal and affiliate personnel, to ensure compliance with local requirements and global policies.
* Maintain awareness of ongoing industry best practices, new QSRs and QMS requirements as they are developed, and implement improvement actions for the QMS.
A background check will be required for this role.
This job description is accurate at the date of publication. However, may change over time.