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Associate Regulatory Affairs Specialist I
Ref No.: 18-12250
Location: Alpharetta, Georgia
Start Date / End Date: 10/01/2018 to 09/30/2019
Duration:0-12 month(s)

Description/Comment:Support regulatory compliance throughout the organization by performing the required activities that assure compliance with domestic and international regulations. Help refine and maintain systems for organizing and retrieving regulatory related information. Responsibilities (fundamental job duties): 1. Maintain regulatory affairs files (e.g. scan, print, file) 2. Research, renew and obtain State Licensing where needed for the I-Flow facility. 3. Support and participate in audits performed by internal and external (e.g., FDA, Notified Body, etc) representatives. 4. Support the implementation of regulatory activities throughout the I-Flow facility. 5. Assist in preparation and execution of Field Action activities. 6. Provide regulatory support for International Registrations, DMRs, Technical files, Design Dossiers, etc. 7. Support MDR Analyst with Medical Device Reporting (MDRs) and Medical Vigilance Reporting (MDVs).

Additional Job Details:Regulatory Affairs Associates – Level I The prepare product submission documentation for regulatory approvals internationally. They will actively participate with developing strategies with project teams, and work with in Region RA counterparts/and or Distributors while aligning with company priorities/initiatives. The individual will execute tasks and play a consultative role by partnering across internal business functions. Responsibilities Expectations: • New product registrations, assessing changes to existing registrations, and maintaining registrations current for assigned products/geographies • Provide analytical, interpretive and evaluative solutions to complex problems through specialized Regulatory Affairs expertise based on an in-depth knowledge of technical (I,e, electronics and software) and business practices. • Support Regional Import/Export Support • Demonstrate a strong degree of knowledge in excel spreadsheet maintenance, use of outlook tools, SharePoint, SAP based systems, and other computer programs used for tracking and reference. • Maintain records and documents for established systems that support regulatory activities and requirements. • Strong attention to detail, highly organized, and able to manage multiple projects simultaneously • Lead projects/initiatives • Develop and remain current on applicable internal procedures/process(s) and applicable regulations Requirements • Bachelor ´s degree ^ • Demonstrated computer skills and strong written and verbal communications • International submission experience preferred/primary author (Canada, Latin America, EMEA, APAC). • Understanding and experience with process, manufacturing, product development, engineer, market research, marketing and legal matters involving medical device industry, preferred.