Our client is a world renowned Medical Device company. The position
can also be REMOTE.
The consultant will be a subject matter leader with a regulatory
background and a detailed working knowledge of cybersecurity
technologies, standards (e.g. ISO **Apply on the website**, ISO
**Apply on the website**), practices, policies, and their application
in a global medical device market. The role will proactively work with
Quality, Regulatory and IT Leaders and business units to implement
techniques that meet defined policies and processes for cyber
resiliency and vulnerability management. Key activities include risk
management (evaluation, control, risk/benefit analysis, residual risk
acceptability and reporting), product and enterprise application
• Minimum Bachelor**Apply on the website**;s degree in Science,
Engineering or Medicine with a minimum of **Apply on the website**
years medical device industry experience, particularly within in vitro
diagnostics or other related regulatory affairs environment.
Experience with Security, Internet Technology, Risk Management and
• Practical knowledge leadership with well-developed interpersonal,
communication skills; management and motivation experience of groups
or indirect teams.
• Extensive knowledge of Quality Systems, including successful
interactions with regulatory bodies.
• Must be able to interpret country regulations and guidelines on
cybersecurity, and to convert these into practical and pragmatic
deliverables. Practical knowledge of regulations (e.g. US FDA
cybersecurity guidance) and standards (e.g. ISO **Apply on the
• Must have prior practical program/project management experience.
• Experience dealing with international locations and cultures
We need : English (Good)