This position focuses on ensuring compliance with EU MDR standards through meticulous documentation assessment, gap analysis, and execution of remediation plans for technical filings related to medical device products.

Key Responsibilities:

• Data Gathering:
• Participate in compiling and organizing required documentation for evaluation.
• Gap Assessments:
• Assess manufacturing documentation, including:
• Device Master Records (drawings, specifications, bill of materials).
• Production routers/instructions, labeling, and related procedures.
• Process flow charts, inspection reports, and validation plans.
• Remediation Plan Execution:
• Perform tasks outlined in the remediation plan, which include:
• Generating and executing validation documents such as change controls, validation plans, protocols, closure reports, and technical summaries.

Qualifications:

• Education:
• Bachelor's degree in Engineering, Quality Assurance, or a related technical field.
• Experience:
• Extensive experience in validation and compliance within the medical device industry.
• Strong understanding of EU MDR requirements and regulatory standards.
• Skills:
• Proficient in validation processes, gap analysis, and technical documentation.
• Excellent organizational and analytical skills.
• Familiarity with FDA, ISO, and EU MDR compliance standards.