Sr MDR/Vigilance Specialist

Sr MDR/Vigilance Specialist

Medtronic Cardiac and Vascular
4-7 years
Not Specified

Job Description

Careers That Change Lives
A career at Medtronic is like no other. We're purposeful, committed, and driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.
In this exciting role as a Senior MDR/Vigilance Specialist, you will be responsible for critically analyzing product events involving Cardiac Ablation Solutions (CAS) products to determine MDR and Vigilance reporting eligibility and report applicable events to the appropriate regulatory agencies. You will also be responsible for delivering on strategic commitments, overseeing daily metrics and work assignments, leading projects, and collaborating cross-functionally to achieve desired results.
A Day in the Life
  • Adhere to policies and procedures to ensure compliance to FDA regulations 21 CFR 803 and 21 CFR 820.198.
  • Ensure documentation of complaint file evaluation and investigation is complete and maintained properly to meet Quality System Requirement regulations.
  • Evaluate incoming Product Events to determine Medical Device Reporting (MDR) and Vigilance reporting eligibility.
  • Initiate and complete regulatory reports for timely submission to FDA and other regulatory bodies.
  • Assess complaint files for missing required information and initiate appropriate attempts to obtain information.
  • Interface and collaborate with senior internal and external customers to ensure appropriate collection of complaint information or resolution of issues in an efficient and professional manner.
  • Promote positive cell team environment including colleague recognition when appropriate.
  • Maintain awareness of new products, government regulations and requirements.
  • Escalate quality issues or complex issues appropriately.
  • Identify, define, and provide solutions to problems that are moderate to difficult and require understanding of multiple issues, job areas or specialties.
  • Collaborate with the team to solve issues identified using a proven problem solving methodologies such as DMAIC
  • Provide in-depth analysis that often provides recommendations on process improvements.
  • May be responsible for entire projects or processes within job area.
  • Coach and review the work of lower level professionals.
  • Other duties as assigned, including but not limited to support for inspections, quality assessments, late report investigations, escalated complaint investigation, training, continuous improvement and corrective and preventive actions (CAPA).

Must Have: Minimum Requirements:
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelor's Degree with 4+ years of work experience in a health, clinical, technical or scientific field OR Advanced Degree with 2+ years of work experience in a health, clinical, technical or scientific field
Nice to Have:
  • Complaint handling experience
  • High level of computer proficiency
  • Excellent problem-solving skills and ability to coach/mentor peers
  • Knowledge of process improvement methodologies
  • Strong organizational and presentation skills
  • Strong attention to detail
  • Strong communication (oral and written) skills
  • Ability to work independently and in a team setting
  • Knowledge of CAS products
  • Knowledge of basic anatomy and physiology

Job Details

Employment Types:

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future. Physical Job Requirements The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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