Regulatory Affairs Specialist

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.- We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on itPosition Overview:The position is accountable for individual projects as well as training and documentation in support of other team members. The Specialist may also review and monitor data and document quality, as requested by the manager. This position will provide administrative support to the department through assistance in the preparation of data analysis, reporting, trending, and documentation review, coordination of complaints and lot qualification data, device history reviews and review and closure of certain categories of complaints. It also requires assessment of complaints against regulatory reporting criteria. The position involves system level comprehension, attention to detail, organization, and constant interaction within the business to the accomplishment of the company goals.**Responsibilities**:- Track all stages of the Complaint Documentation process including:- Reportability Determination,- Data Analysis,- Reporting and Trending,- Documentation Review,- Coordination of complaint and lot qualification data,- Device history reviews,- Review and closure of certain categories of complaints.- Maintain accurate documentation and files related to special projects, complaints and lot Qualification.- Review and analyze lot documentation (DHR’s) to determine if there are any anomalies that may have related to reported product failures.- Support database development and reporting capabilities related to the complaint / reliability department needs.- Assist during FDA, ISO or other third party or internal audits.- Train others on the requirements of the Complaint Coordinating activities, including follow-up with the Customer Care Group.- Support review and investigation of adverse events- Perform basic product review and failure analysis.- Performs other duties as required.Education and Experience:Minimum Requirements:- Bachelor’s degree or 3 years of demonstrated experience in medical device complaint evaluation or vigilance reporting- Complaint handling experience preferred- Minimum of 1-2 years’ experience in data management, record keeping, and trouble shooting in the Medical Device field, or other transferable experience related to organization, technical aptitude and data management.Preferred Skills and Competencies:- Willingness to pursue additional learning and build qualifications in a professional field, as required.- Ability to demonstrate system level expertise of databases with the ability to train on these identified systems.- Effective verbal and technical writing skills. Ability to communicate at multiple levels of an organization.- Ability to organize and judge priorities.- Excels at generating and maintaining organized and accurate records, PC skill, word processing, spreadsheet, database.- Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.Physical Requirements (if applicable):- This position is a desk job and requires sitting for extended periods of time."