Regulatory Operations Specialist

Location: Mounds View, Minnesota
Posted On: 8/9/2017
Job Code: ROS_MN2128
Job Description
This is a contract position in MDT CSH Regulatory Operations.The Regulatory Operations contractor uses strengths in organization, efficiency, and detail orientation to ensure the accuracy with which Regulatory data is entered into MDT Regulatory Information Management (RIM) systems, and the efficiency with which it is retrieved. This work helps to preserve MDT Coronary Structural Heart’s (CSH) product compliance rates and achieve the business objectives of the CSH Regulatory Affairs function.

The Regulatory Operations contractor will be assigned as an individual to various data and information management-related tasks and may also be a team member in similar types of group projects. Data management tasks often require collaborating with other Regulatory Operations and Regulatory Affair Specialists, as well as individuals working in MDT cross-functional groups.
Typical duties will include searching for documents in various MDT systems, saving them to network shared folders, and transposing data from the shared folders into regulatory information management (RIM) systems. This position will assist higher level specialists by preparing information for and otherwise supporting process and system improvement projects and tasks.

• Entering, maintaining, retrieving, and reporting regulatory data from various systems and sources.
• QC’ing spreadsheets and other manually-entered data sources.
• Maintaining informal tools used to track and communicate Regulatory data (e.g., Sitebuilder, informal spreadsheets).
• Monitoring centralized mailboxes and disseminating tasks and requests.
• Performing all duties according to prescribed regulatory and quality system requirements.
• Assisting in various ad hoc projects and other tasks as requested.

BA or BS degree + at least 1 year of experience

• Previous MDT / Regulatory / Regulatory Operations experience
• Experience in regulated industry and some knowledge of global regulations
• Experience using documentation management systems, such as Agile, Documentum, Insight Publishing and Tracking, or others
• Strengths in attention to detail and accuracy
• Excellent task management and organization skills
• Mastery of content development, publishing, spreadsheet, presentation, and communication tools such as Word, Acrobat, Excel, Powerpoint, Visio, WebEx, and others
• Advanced written and verbal communication skills
• Ability to work individually and collaboratively under pressure in a dynamic environment
• Ability to successfully juggle competing priorities
• Ability to learn and adapt to changes in technology, processes, and requirements
• Excellent problem-solving skills
Category:IT  code:new
Job Requirements
Information Management, MS Excel, Compliance, Management, MS Access, MS Word, Documentum

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Contact Details
Ebrahim Sayarwala