Senior Product Development Specialist
4 days ago
We are seeking an experienced Senior Product Development Specialist to join our team.
The successful candidate will play a key role in ensuring compliance with design control requirements outlined in quality management systems and relevant regulations.
- Supporting device development programs throughout the design lifecycle;
- Maintaining and providing guidance on Design History Files for various program types;
- Collaborating with affiliated sites, collaborators and third parties to establish objective evidence and controls;
The candidate will also support risk management activities through the implementation of ISO 14971:2019 and possess a demonstrated understanding of GMP, quality management systems and relevant regulations.
Key Requirements:
- Education – Degree or Masters in engineering or science/life science;
- Industry experience in medical devices or pharmaceuticals;
- Min 5–7 years at a similar level or 5–10 years general experience in industry;
- Direct experience of device development and manufacturing operations in a GMP environment;
- Experience in implementing device design controls and ISO/FDA requirements as applicable to device design;
This is an excellent opportunity for a motivated engineer to contribute to the development of innovative medical devices.
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