Systems Engineer (EU MDR) - Remote

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Written by AI from the job title and company, not by DivIHN Integration Inc, so some details may not match this job. The employer's own page has the real description.

Job Overview

The Systems Engineer (EU MDR) at DivIHN Integration Inc. will play a pivotal role in ensuring compliance with the European Union Medical Device Regulation (EU MDR). This remote position involves collaboration with cross-functional teams to develop, implement, and maintain systems that support regulatory compliance while optimizing operational efficiency. The ideal candidate will possess a deep understanding of medical device regulations, risk management, and quality systems, coupled with technical expertise to assess and enhance the company’s processes and products within stringent regulatory frameworks.

Job Responsibilities

• Develop, implement, and manage systems to ensure compliance with EU MDR requirements.
• Conduct risk assessments and devise strategies to mitigate risks associated with medical devices.
• Collaborate with product development teams to integrate regulatory requirements into product designs.
• Participate in audits and inspections, providing necessary documentation and evidence of compliance.
• Support the preparation and submission of regulatory documentation to ensure timely market access.
• Provide training and guidance to internal teams on compliance and regulatory matters.
• Monitor changes in EU regulations and update internal systems and processes accordingly.
• Engage in continuous improvement initiatives to enhance compliance systems and processes.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• Minimum of 5 years of experience in systems engineering within the medical device industry.
• Comprehensive knowledge of EU MDR and relevant regulatory frameworks.
• Experience with risk management principles and practices in a regulated environment.
• Strong analytical skills, with the ability to assess complex systems and processes.
• Excellent communication and interpersonal skills for effective collaboration.
• Proficiency in project management methodologies and tools.
• Ability to work independently and manage multiple priorities in a remote setting.

Technologies & Tools

The Systems Engineer will utilize a variety of technologies and tools relevant to regulatory compliance and systems engineering. Proficiency in software such as Quality Management Systems (QMS), Electronic Lab Notebooks (ELN), and Project Management tools is essential. Familiarity with data analysis software, risk management frameworks, and regulatory submission platforms will also be beneficial to ensure that all compliance documentation is accurate and up-to-date.

Ideal Candidates

Ideal candidates for this position will demonstrate a proactive and solution-oriented mindset, with the ability to navigate complex regulatory environments effectively. They possess strong critical thinking skills and an acute attention to detail, ensuring that all processes adhere to regulatory standards. The ability to communicate complex regulatory concepts clearly and succinctly to cross-functional teams is paramount. Furthermore, candidates should be adaptable, showcasing resilience and an eagerness to learn in a dynamic, fast-paced environment.