Cyber Security Subject Matter Expert
This role is responsible for supporting the clients Secure Lifecycle Program (SLP), primarily in accordance with the clients policy and process requirements
Responsibilities and Duties:
- Acts as the point of contact providing regulatory compliance and quality guidance and expertise related to the scope of the SLP policy and process
- Be responsible for the implementation, oversight and improvement of the SLP policy including dependencies with Production and Process Control, Design Control, Supplier Management, Distribution Control, Risk Management, Computer System Validation, CAPA/Non-Conformance, Quality & Supplier Audits, Packaging & Labelling Control, and others, as appropriate
- Provides SLP guidance and direction to the business units in the development, implementation, maintenance and improvement of the Quality Management Systems for product and non-products; communicates the importance of an effective and compliant Quality Management System w.r.t. SLP to all employees and assesses and reports on effectiveness to program management
- Responsible for training or overseeing training of all staff relative to applicable Quality Management System requirements of the SLP policy and process. Ensures Quality and Regulatory personnel professional development through interactions (e.g. on the job learning) and formalized training of SLP practices
- Measure effectiveness of the SLP process adoption in the Quality Management System and ensures continuous improvements
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Responsible to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job
- Perform other duties and projects as assigned
- Key position competencies: Problem solver, effective trainer, independent worker, excellent delegation ability, managerial courage and conviction, interpersonal savviness, able to manage vision and purpose, ability to work with cross cultural teams, composure under pressure and able to build effective teams
- Minimum Bachelor’s degree in Science, Engineering or Medicine with a minimum of 10 years medical device industry experience, particularly within in vitro diagnostics or other related regulatory affairs environment. Experience with Security, Internet Technology, Risk Management and Privacy Practices
- 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 27001)
- Must have a strategic perspective and be capable of synthesizing information and prior experience from multiple sources to build efficient and successful SLP compliance and quality strategies for the organization
- Must be able to work effectively in a cross-functional environment, achieving regulatory compliance though teamwork, facilitation and influence
- Must have demonstrated written and verbal presentation skills, including ability to articulate complex concepts with clarity. MUST have advanced proficiency in MS PowerPoint and Excel
- Must be well organized and attentive to detail, approaches tasks in a rational manner and capable of providing support and direction to others
- Must have prior practical program/project management experience.
To apply for this position please contact Chloe Walsh at Sigmar Recruitment T: +353 91 455305 E: firstname.lastname@example.org
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