Director of Software Design and Validation
Full time, Direct hire
Contact Mary Nugent at firstname.lastname@example.org
- Bachelor’s Degree in Science with at least 15 years’ experience in medical device industry, working within quality system framework for software design controls and validation.
- Knowledge of cGMP (FDA and HC QSR) and ISO regulations.
- Microsoft Word, Outlook, Excel, PowerPoint, Access
- In depth understanding of Design Controls and Validation requirements in support of Software products. Strong communication and interpersonal skills. Ability to obtain cooperation, develop a consensus and lead or influence cross-functional teams.
- In conjunction with Corporate staff, develop and formulate final decisions on key regulatory and compliance issues affecting Sysmex products, services and customer support issues. Manage departmental budget and objectives to achieve business goals and project timelines.
- Must be able to assimilate relevant technical, regulatory and compliance information and formulate suitable strategies and tactics to satisfactorily resolve complex problems.
- Strong practical knowledge of compliance and regulatory environments. Knowledge of hematology products and marketplace preferred but not required.
- 10% – 15% travel
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