|
WHAT
IN
Regulatory Operations Spec
Job
Medtronic
US
-
Santa Rosa,
California
Job Code - 69662
Position - Full Time - Regular
Job First Active on: Thursday, November 05, 2009
APPLY TO THIS JOB (You will be applying directly to Medtronic for this position!)
JOB DESCRIPTION: Regulatory Operations Spec
Primary responsibilities include the preparation, publication, quality control and delivery of paper and electronic regulatory submissions. Submissions are produced with electronic publishing tools in compliance with internal and external document standards. Prepares, submits, tracks, indexes and archives paper and electronic submissions, as well as related information including approvals, amendments, annual reports, and FDA/Regulatory Agency communications. Additional duties include developing international device product registrations, maintaining global product registrations, and developing department processes and systems.
REQUIREMENTS - QUALIFICATIONS: Regulatory Operations Spec
• Responsible for assembly and electronic publishing and filing of global regulatory submissions. This includes project management of large submissions (i.e., original PMA submissions); timely and accurate information for internal and external customers per deadlines; gathering and compiling metrics for submission processing and maintaining controlled documentation; records retention and IT systems for submissions; interpreting and enforcing Regulatory documention handling, formatting standards, policies, and standard operating procedure requirements.
• Responsible for implementation and support of department processes and systems for document management, publishing systems, and department procedures used within Coronary/Peripheral Regulatory. This includes solving complex issues related to associated business processes, first line user support, training system users, submitting enhancements, participating in requirements analysis, standard operating procedures and work instructions and assisting with system testing and validation when requested.
• Provides technical support that may include data coordination, project status, data review, tracking and coding, regulatory metrics reporting, and providing summaries of regulatory intelligence reports to the regulatory team. Create and maintain systems to streamline accessiblity to key information.
• Responsible for activities related to enterprise-wide regulatory management systems, including system coordination, training others, developing implementation plans and providing input into system designs.
• Responsible for helping to develop and to manage international product registrations, including working with the Coronary/Peripheral regulatory team and OUS geography specialists to respond to requests for information.
• Responsible for participating in lean sigma projects within the department to improve processes. This includes identifying and implementing metrics to enhance business efficiencies.
• Receive and process queries from other parts of the core business (e.g., blocked orders, clarifying product lines, etc.) Support may extend outside business hours.
• Assist with design, management, and update of internal websites.
Technical
Competency with various software packages including Microsoft Word, Excel, Adobe Acrobat, Documentum, SharePoint, and SiteBuilder, organizational skills, detail oriented, and effective project management skills.
Strong Technical Writing and Publishing experience
Conceptual
Flexible with changing priorities, self starter, strong work ethic, attention to detail
Interpersonal
Excellent oral and written communication skills, team player
Medtronics
Back To Results
Apply to this job!
View Company Jobs
Free Career Test
Your Resume on 75 Job Sites
|
