What are the responsibilities and job description for the Sr. Compliance Engineer position at Global Recruiters of Dublin (GRN Dublin)?
PURPOSE AND REPORTING STRUCTURE:
The Senior Engineer/Consultant will report to the MethodSense Executives and experienced team leaders in support of customer projects.
Responsibilities
Leads and executes complex Quality Project tasks and assignments with minimal supervision to:
- Develop and implement comprehensive client Quality Management Systems, creating custom solutions as needed.
- Oversee the implementation of complex Quality Management System procedures, ensuring compliance and efficiency.
- Lead and conduct client internal and supplier audits, providing detailed analysis and improvement recommendations.
- Perform in-depth reviews of medical device requirements and specifications, determining gaps and proposing solutions.
- Manage the creation and maintenance of Design History File documents, ensuring regulatory compliance.
Leads and executes complex Regulatory Project tasks and assignments with minimal supervision to:
- Develop comprehensive regulatory strategies and roadmaps for clients.
- Manage the preparation and submission of complex regulatory submissions.
- Conduct and oversee thorough risk assessments and mitigation strategies.
- Lead verification and validation activities, including Software validation and Human Factor studies.
- Represent clients in pre-submission and submission regulatory meetings, preparing and delivering presentations.