Sr MDR Vigilance Specialist_Career 2.0
Careers that Change Lives
Review, evaluate, classify and perform follow up activities on all product complaints relative to the identity, quality, reliability, safety and effectiveness of medical devices. Evaluates for reporting criteria to Government Agencies to determine if the event reasonably suggests a device may have or could have caused or contributed to a death or serious injury.
A Day in the Life
Intake of source documents, promote them to complaints, follow-up with Reps, determine Reportability, file Regulatory Reports and write Investigation Summaries based on technical product analysis information provided by the plant.
Must Have
Job Responsibilities
· 2+ year break in their career
· 8+ year professional engineering work experience
· 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.
Minimum Qualifications
· Bachelor degree; Engineering or Science degrees preferred (e.g. 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.
About Medtronic
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. For Office Roles: 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)
