Regulatory Engineer

Job Description

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 on all complaints Determines Reportability of complaints and submits Regulatory Reports 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 RTG, such as Technical Services, Failure Investigation, R & D, Manufacturing and Engineering Interacts with groups external to Medtronic RTG, such as customers, vendors, health care professional Minimum Qualifications Bachelor degree; Engineering or Science degrees preferred (eg ECE, Biomedical Engineering, ME) 5 8 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 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 medical device standards Knowledge of FDA, MEDDEV, Canadian Regulations Technical Writing experience