Role Overview:
We are seeking an experienced professional to lead design control and risk management for medical device and combination product development. The role involves overseeing product lifecycle activities, ensuring regulatory and quality compliance, and collaborating with internal teams and external partners to drive safe, effective, and high-quality products.
Key Responsibilities:
* Lead design control and risk management activities to support clinical trials and commercial product approvals.
* Oversee design validation activities, including human factors and usability assessments.
* Collaborate with external design companies, suppliers, and manufacturing partners to ensure quality and regulatory compliance.
* Support investigations, device issue resolution, and continuous improvement initiatives.
* Contribute to regulatory submissions and audits, ensuring alignment with global quality standards.
Requirements:
* BSc/MSc/PhD in a relevant science or engineering field.
* Experience in combination product or medical device development, including design controls and risk management.
* Knowledge of ISO 13485, ISO 14971, 21 CFR 820/4, EU MDR, and GMP.
* Familiarity with human factors engineering, usability assessments, and device manufacturing processes.
* Strong attention to detail, excellent communication skills, and ability to work collaboratively across teams.
Willingness to travel as needed.
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