Vacancy Description
Description
We are seeking a skilled and proactive Engineering Lead to support a long-term EU MDR remediation project for a leading medical device company. This remote consulting role will be responsible for leading the engineering workstream across two key phases: Gap Assessment and Technical File Remediation. The Engineering Lead will play a critical role in evaluating existing documentation, identifying compliance gaps, and driving remediation activities to ensure alignment with EU MDR requirements. In Phase 2, the Engineering Lead will lead a team of engineers to execute remediation tasks efficiently and effectively.
Skills
Mechanical engineering
Top Skills Details
Mechanical engineering
Additional Skills & Qualifications
Additional Skills & Qualifications • Prior consulting experience in medical device regulatory or compliance projects. • Experience with ISO and 21 CFR Part 820. • Proficiency in document control systems an...
We are seeking a skilled and proactive Engineering Lead to support a long-term EU MDR remediation project for a leading medical device company. This remote consulting role will be responsible for leading the engineering workstream across two key phases: Gap Assessment and Technical File Remediation. The Engineering Lead will play a critical role in evaluating existing documentation, identifying compliance gaps, and driving remediation activities to ensure alignment with EU MDR requirements. In Phase 2, the Engineering Lead will lead a team of engineers to execute remediation tasks efficiently and effectively.
Skills
Mechanical engineering
Top Skills Details
Mechanical engineering
Additional Skills & Qualifications
Additional Skills & Qualifications • Prior consulting experience in medical device regulatory or compliance projects. • Experience with ISO and 21 CFR Part 820. • Proficiency in document control systems an...
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