Principal MDR/Vigilance Specialist

Principal MDR/Vigilance Specialist

Requirements

• Bachelor’s Degree with 7+ years of Quality and/or Regulatory experience OR advanced degree with 5+ years of Quality and/or Regulatory experience

Responsibilities

• Ensure complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies
• Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries
• Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements
• Lead or leverage cross functional teams to evaluate, develop and manage projects for key business processes
• Oversee and manage the operational aspects of ongoing projects and serves as liaison between project team and stakeholders
• Assess project issues and supports project team in development of resolutions to meet goals and objectives
• Understand current and upcoming Medical Device Reporting (MDRs) and EU Vigilance Reporting requirements by regulatory bodies and ensure adequate implementation or regulations

Preferred Qualifications

• Demonstrated ability to collaborate and influence in a matrixed environment and to work effectively with in-house functional team
• Excellent verbal, written and presentation communication skills
• Proven ability to build and facilitate strong, productive working relationships with a wide variety of cross-functional and customer contacts
• Program management experience in the medical device, aerospace, automotive or other highly regulated industry
• Experience devising and implementing streamlined processes and strategic programs to improve efficiency, timeliness, and productivity
• Experience in leading within matrix organizations requiring strong influence management skills
• Change agent –willingness and ability to lead and institute change
• Influence management skills; experience working collaboratively at all levels in matrix environment to build and maintain the positive relationships required to accomplish organizational goals
• Excellent communication skills and interpersonal/team effectiveness with ability to succinctly and accurately communicate to various levels of management and employees
• Business acumen; ability to think and act from an overall ‘best for the business’ perspective
• Results oriented; strong sense of urgency
• Strong analytical, planning, organization and time management skills to effectively develop and execute comprehensive programs and budgets
• Effective decision-making skills with ability to negotiate and balance decisions and priorities across needs of several functional departments and willingness to make tough decisions
• Makes timely decisions in the face of risk and uncertainty