Product Development Manager

Organization
Our client is a university based genomics/diagnostics test development and research organisation with approval and funding under the prestigious Marie Curie Fund
Job Location
Dublin
Ireland
Salary
Negotiable based on experience
Benefits

Negotiable based on experience

Job Description

JOB TITLE:
Product Development Manager
REPORTING TO: Chief Executive Officer
Main Role
Lead the development of new Cancer Diagnostic tests, post-discovery, through the regulated stages of commercial product development.
Responsibilities
 Lead a team of Product Development Scientists to successfully complete within strict timelines the Development cycle for new cancer diagnostic tests
 Ensure compliance with Design Control procedures per FDA QSR and ISO13485, establishing and maintaining Design History Folders to capture outputs from key design stages and demonstrate traceability between Design Inputs and Design Outputs.
 Maintain quality records throughout the development process to ensure regulatory approval and ongoing manufacturability of new products.
 Liaise with Pathologists and Clinical Trial Design advisors to create appropriate Clinical Trial Design plans and manage successful execution of Clinical Studies
 Liaise with external third parties, Oncologists, Pathologists, & Laboratory Scientists to ensure Developed tests meet Clinical acceptance criteria and end-user requirements
 Provide support to Marketing & Sales to ensure all required Technical and scientific information is available in an understandable format to support the marketing efforts.

Requirements

PRINCIPAL QUALIFICATION REQUIRED:
Preferably a PhD in the area of molecular biology. At a minimum, the successful candidate will hold an MSc or equivalent in a biological science.

You will also need industry experience in assay development.

How to Apply

Please forward your enquiry to fiona@cregg.ie

About Our Organization

Cregg is a recruitment specialist in biotech with offices throughout Ireland.

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