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Job Details

Medical Device Technical Expert – Human Factor

Company: Key People Limited
Location: Basel
Reference: mc22411
Closing Date: 22 Sep 17
Type: Contract
Salary (£): 100,000+
Benefits:

Job Summary:

* Run and lead technical development activities for medical devices e.g. Autoinjector, Safety syringes. * Generate Design Controls documentation while contributing to a high-quality Design History File (DHF) for parenteral delivery injection systems. Author and Reviewer of DHF documents.

Requirements:

Requirement for the role are:
• Excellent technical writing skills (e.g., Design Controls)
• Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive)and of combination products (US)
• Experience in Product Design and Design for Manufacturing
• Good technical knowledge of primary containers development
• Good technical knowledge of autoinjector development
• Good communication skills
• General understanding of Human Factors Engineering and Risk management
• General understanding of clinical trial processes and requirements
• General understanding of pharmaceutical development

Other Tasks:
• Support DRA to prepare Medical Device/Combination Product pre-registration documents and answer health authority questions.

Apply for this job: Medical Device Technical Expert – Human Factor

Contact Information:

Address:  Head Office
Catherine House
Adelaide Street
St Albans
Hertfordshire
AL3 5BA
England
Tel:  Tel: 44 (0) 1727 811634
Fax:  Fax: 44 (0) 1727 844838
Website:  Visit Our Web Site

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