Systems Engineer (EU MDR) - Remote | WFH

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Job Overview

The Systems Engineer (EU MDR) will be responsible for the successful design, implementation, and maintenance of systems required to comply with the European Medical Device Regulation (EU MDR). This role involves collaborating closely with cross-functional teams to ensure that all systems meet regulatory standards while maintaining high efficiency and effectiveness. The ideal candidate will leverage their expertise in systems engineering to drive compliance initiatives, facilitate audits, and support quality assurance efforts, all while working in a remote environment.

Job Responsibilities

• Design, implement, and maintain systems in compliance with EU MDR regulations.
• Conduct risk assessments and establish mitigation strategies to ensure regulatory compliance.
• Collaborate with project teams to integrate compliance requirements into project plans.
• Support quality assurance processes, including documentation and auditing for EU MDR standards.
• Provide technical guidance and support to both internal and external stakeholders regarding system functionalities and compliance issues.
• Lead training initiatives to enhance systems engineering skills and regulatory awareness among staff members.
• Stay updated on changes in EU MDR regulations and assess their impact on existing systems.
• Prepare and present reports on compliance status and system performance to senior management.

Qualifications

• Bachelor's degree in Systems Engineering, Computer Science, or a related field.
• Minimum 3 years of experience in systems engineering roles, preferably in the medical device industry.
• Proven knowledge of EU MDR and other relevant medical device regulations.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Proficiency in system engineering tools and methodologies.
• Ability to work independently and manage multiple projects concurrently.

Technologies & Tools

The Systems Engineer will utilize a range of technologies and tools, including system modeling software, compliance management systems, risk assessment frameworks, and auditing tools. Familiarity with project management software, such as JIRA or Asana, is advantageous for tracking project progress and collaborating effectively within teams.

Ideal Candidates

Ideal candidates for the Systems Engineer (EU MDR) role will exhibit a strong commitment to regulatory compliance and a systematic approach to problem-solving. They will demonstrate exceptional attention to detail and possess a proactive attitude towards achieving project objectives. Strong analytical skills, combined with effective communication abilities, will be essential in collaborating with diverse teams and presenting compliance-related information to stakeholders. The ability to adapt to changing regulations and work in a fast-paced environment will set the successful candidate apart.