Senior MDR Vigilance Specialist

• Evaluates incoming complaint information and maintains the record in the electronic database.
• Performs follow up activities to obtain additional information. Use and maintain database(s), provide analysis and trending data all on complaints.
• Determines Reportability of complaints to Government Agencies.
• Identify and document appropriate complaint categories to assure trend accuracy within the complaint database.
• Writes investigation summaries based on technical product analysis information provided;
• Ensures record documentation is maintained in a constant state of audit readiness per internal policies.
• Liaison with groups who perform additional investigation and who prepare written record of investigation.
• Interact with Technical Service, Manufacturing, R&D, and Quality Assurance, as needed, during the course of complaint processing.
• Provide basic technical expertise and assistance in handling complaints to comply with current FDA and International reporting regulations.
• Reviews and interprets risk management documentation as it applies to the complaint event.
• Interacts with multiple departments within Medtronic - such as Technical Services, Failure Investigation, R & D, Manufacturing and Engineering.
• Interacts with groups external to Medtronic - such as customers, vendors, health care professional
• Initiate process improvements through Lean Sigma, DMAIC and automation

Required Knowledge and Experience

• Bachelor degree; Engineering or Science degrees preferred (eg SW,EE, ME, Biomedical Engineering)
• 9+ years quality assurance or regulatory experience in medical or pharmaceutical industry.
• Computer literate with skills in Word, Excel, Access, PowerPoint and database trending analysis
• Strong typing skills and ability to write business documents with minimal supervision.
• Strong verbal and written communication skills and ability to work in a team oriented environment
• Ability to be proactive and lead initiatives technically
• Ability to multitask.
• Ability to understand the functionality / intended use of complex medical devices.
• Minimum travel may be required

Nice to Haves

• Knowledge of medical devices, their development and quality control.
• Knowledge of FDA, MEDDEV, Canadian Regulations.
• Technical Writing experience.