Technical Manager

Technical Manager - Regulated Medical Devices, Huddersfield (hybrid)

Salary: Competitive + benefits

Paxman is a global leader in scalp cooling technology, improving the lives of cancer patients worldwide. As they continue to innovate and expand internationally, we're looking for an experienced Technical Engineering Manager to have responsibility for the Technical Files for all Paxman products, ensuring compliance globally.

Areas of responsibility around Technical Files:

Management of the Design Control Matrix and Risk Management File

Accountable for the Clinical Evaluation File and Usability File

Overall sign-off of the Technical File along with other heads of departments.

Leading audits of the technical file

Other areas of responsibility:

Plan and manage technical CAPAs

Manage the introduction of engineering changes to product development

Ensure all devices meet efficacy and safety standards when used during its intended use and possible misuse

provide technical specs to suppliers and work closely with suppliers to agree processes

Ensure labelling and documents are compliant with regulatory legislation

Supporting new product development and ongoing product lifecycle management.

Support and strategic planning for any new products from a technical perspective

We're looking for someone with:

Experience at a senior level of managing technical documentation within a regulated manufacturing or medical device environment.

A strong understanding of medical device regulations and quality management systems (ISO 13485/MDR desirable), as is ISO 14971

Exposure to technical documentation and a regulatory compliance environment

Experience with design control, risk management and technical file maintenance.

Excellent organisation skills with the ability to manage multiple projects and stakeholders.

Team leadership and mentoring skills

In return you will have the opportunity to:

Lead a growing technical function

Mentor and develop your team

Have significant autonomy

Gain exposure to a newly launched medical device

work in a supportive, people-focused culture

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