Compliance Engineer responsible for key requirements and safety documentation for regulatory approvals. Collaborating across teams to ensure regulatory compliance and assist in third-party testing.
Responsibilities
Compiling key requirements and safety documentation required for global regulatory clearances and approvals
Responsible for top-level Design History File documentation to demonstrate regulatory compliance with safety standards
Collaborating with development, regulatory, quality software, production, and service teams
Assisting in planning and managing third-party testing activities for safety and EMC standards
Training and mentoring others to understand regulatory requirements, standards, and guidance
Requirements
Degree in science / engineering-based subject or a higher-level technical qualification in an engineering subject and more than 3 years’ experience in regulatory compliance, risk management, quality management for medical devices or comparable experience in an equivalent role for non-medical devices.
Product requirements relating to safety standards (i.e. ISO, IEC, etc)
Testing methods
Documents such as Initial Safety Design Reviews
Excellent attention to detail.
Excellent prioritising, organisational, and interpersonal skills. Fluent in English, speaking and reading ability.
Computer Proficiency with MS Office (Word/Excel/Access/Outlook).
Strong organisational skills e.g. participating in meetings, setting/agreeing actions and driving them to closure, monitoring actions for effectiveness etc.
Ability to work in a fast-paced environment with multiple tasks/projects.
A critical thinker with good attention to detail and problem-solving skills as well as a demonstrable level of understanding of technical areas.
Must have a detail-oriented attitude with a “can-do” and adaptable attitude and ability to work in a team environment as well as individually with minimal supervision.
Willingness to accommodate a flexible working schedule that may involve evening and weekend working hours, depending on project requirements.
Benefits
Vision RT is an Equal Opportunity / Affirmative Action employer
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