Regulatory Approvals Group
Component Regulatory Manager
Location - UK and Europe
£50-60k
Reporting to the Business Unit Director Procedure Trays.
This exciting and rare opportunity to work within International Healthcare for one of Europe's largest Medical Devices suppliers, will offer the ideal candidate a fantastic career challenge. Spending significant time on site directing the regulatory aspects of our fast growing Eastern European based operation operation, you will be a highly motivated, self-starting team player sharing the vision of our client to continue long term commercial growth whilst maintaining the highest standards of quality.
You will possess:
A Batchelor degree in life or material science or equivalent or other appropriate curriculum.
Extensive and applicable experience in Sterile Medical Device industry with focus on experience in Regulatory Affairs and Quality Assurance.
The role is to ensure the overall approval for use for all of the incoming components used in the Procedure Tray/pack business. This covers the evaluation of all component suppliers, monitoring of medical devices and classification, inspection protocols and meticulous attention to the highest quality and safety standards.
The European team you will lead are based in the Czech Republic and comprise a multi-lingual Component Approval team of seven who require inspirational leadership to drive and direct overall compliance.
Core Competencies
- Component approval
- Cross-organisational relationships including manufacturing, purchasing, research and development and sales and marketing.
- Compliance with international legislation and guidelines
- Develop and write clear justifications for new products using relevant standards, risk management, product classification etc.
- Supplier guidance and advice
- CE marking
- Manage project teams through close review of objectives and targeted quantative and qualitative outcomes.
- Materials knowledge
- Significant single use medical device experience
- Initiate and perform non-conformity investigations
Please ensure your CV and covering letter demonstrates your competencies in the key areas highlighted.
Contact Liam on 0161 868 2216 or email: Liam.Fleming@srg.co.uk