Senior Manager Compliance and Certification coordinating external audits and compliance at D - Trust GmbH in Berlin. Ensuring regulatory adherence and leading audit preparation and execution.
About the role
- 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
- Strong values, clear mission, and a bright future
Job title
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