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Role Overview:
Lead design control and risk management for medical device and combination product development. Ensure compliance with quality and regulatory standards throughout the product lifecycle, collaborating with internal teams and external partners.
Key Responsibilities:
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Manage design control and risk activities, supporting clinical trials and commercial approvals.
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Support design validation, including human factors/usability assessments.
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Evaluate external suppliers and manufacturing partners for quality compliance.
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Assist with regulatory submissions and quality audits.
Requirements:
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BSc/MSc/PhD in relevant science or engineering field.
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Experience in combination product/device development and risk management.
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Knowledge of ISO 13485, ISO 14971, 21 CFR 820/4, and EU MDR.
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Familiar with human factors engineering and device manufacturing.
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Strong attention to detail, communication skills, and teamwork.
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GMP understanding; ability to travel as needed.
