A day in the Life
This position is part of the CSH Shared Services Regulatory Operations group and supports regulatory submission development teams and regulatory processes. This position will also support audits, help develop systems, and manage regulatory operation processes. Additional duties include technical writing, compiling international device product registrations, maintaining global product registrations, and developing department processes and systems.
In this role you will:
Ensure submissions are produced with electronic publishing tools in compliance with document management standards.
Responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, and providing input to systems designs.
Ensures continuous efficiency and effective process improvement measurements are conducted to evaluate external vendors.
Prepares, submits, tracks, indexes and archives paper and electronic submissions including information, amendments, annual reports, general correspondence, adverse event reporting, and promotional materials.
IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME
Must Have: Minimum Requirements
• Bachelors Degree with 2+ years experience in regulatory, engineering or clinical.
Nice to Have:
• Intermediate knowledge of word processing, spreadsheet, database and graphics presentation applications (Microsoft Office, Adobe Acrobat, Documentum, SharePoint, and SiteBuilder). Organizational skills, detail oriented, and effective project management skills.
• Flexible with changing priorities, self-motivated, strong work ethic, attention to detail, works well under pressure in a dynamic environment. Tactful, exercises independent judgment and discretion, professional presentation, advanced communications skills (written and oral), team player.
Corporate / junior
Santa Rosa , United States