Mdr/Vigilance Specialist

MDR/Vigilance Specialist Overview

• The MDR/Vigilance Specialist role focuses on monitoring medical device surveillance programs for compliance and regulatory requirements.
• Collaborate with cross-functional teams to ensure accurate reporting and maintenance of Medical Device Reports (MDRs).
• Analyze clinical databases to extract adverse event data and integrate findings into unified databases.
• Develop and update work instructions and complaint codes for cardiovascular surgery products.
• Act as a liaison internally and externally to meet regulatory reporting requirements effectively.
• Provide mentorship to entry-level professionals and contribute to project milestones.
• Work onsite four days per week to collaborate directly with teams and stakeholders.
• Opportunity to transition from contract to permanent based on performance and project needs.

MDR/Vigilance Specialist Key Responsibilities & Duties

• Monitor and evaluate the company’s medical device surveillance program for compliance and accuracy.
• Develop protocols and process adverse reports to meet regulatory standards.
• Review clinical databases to extract and standardize adverse event data.
• Update work instructions and complaint codes based on findings and industry standards.
• Collaborate with cross-functional teams to ensure project milestones are met effectively.
• Communicate findings and updates to internal stakeholders for informed decision-making.
• Provide guidance to junior team members and support their professional development.
• Ensure adherence to industry standards, including geometric dimensioning and tolerancing (GD&T).

MDR/Vigilance Specialist Job Requirements

• Bachelor’s Degree in Engineering, Science, or a technical field with 2+ years of relevant experience.
• Preferred: Master’s Degree in Mechanical Engineering or related engineering discipline.
• Experience in medical device design and application of statistical methods.
• Certified Quality Engineer or Reliability Engineer certification is highly desirable.
• Proficiency in complaint handling and knowledge of IMDRF or complaint coding.
• Strong communication, presentation, and team collaboration skills.
• Ability to manage multiple tasks and prioritize effectively in a dynamic environment.
• Working knowledge of industry standards, including specification development and GD&T.