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Regulatory Affairs Specialist

  • Location: Fruitville, Florida, 34232
  • Job Type:Contract

Posted 24 days ago

Terrific Long-Term Contract Opportunity with a FULL suite of benefits!

Position:Regulatory Affairs Specialist

Location: Fruitville, FL, 34232
Term: 6 months

Day-to-Day Responsibilities:
  • Responsible for managing the documentation process of installation and certification of Care Communication products in a timely and accurate manner.
  • Oversees, manages, processes and updates the documentation and Device History Record process of Care Communication products.
  • Review all documents related to the Care Communications Device History Records prior to submission to document control in accordance with FDA acceptance activities standards.
  • Coordinate with members of the service organization to follow up on incomplete items.
  • Supports quality organization in Quality Systems Audits as the subject matter expert for inspection and review of Device History Record process and records.
  • Provide guidance and training on processing documentation associated with Care Communications work orders and Device History Records.
  • Collaborate with members of the service and quality organizations to ensure compliant investigation details and resolution notes are appropriately documented.
  • Responsible for creating and maintaining exceptional customer value, employee value, and shareholder value in an environment that is demanding and ever changing due to customer expectations and practices, and developments in technology.
  • Assist in continuous improvement initiatives, projects, and/or training.
  • Assist with special projects on an as-needed basis.
  • Other duties may be assigned. Education, Experience, and Qualifications
Is this a good fit? (Requirements):
  • Bachelors Degree in Business Administration, Management or Engineering required.
  • 2-5+ years of experience required.
  • Demonstrated proficiency with MS Office (Outlook, Word, Excel, PowerPoint) and Teams.
  • Demonstrated advanced proficiency with Microsoft Excel, including but not limited to: data filters, pivot tables, VBA programming, and macros.
  • Experience with MS Dynamics CRM and JD Edwards required.
  • Must be able to perform each essential duty satisfactorily.
  • Ability to learn technical product design and operation of medical devices.
  • Ability to communicate effectively and clearly to a wide range of customers.
  • Ability to define problems, identify solutions and follow through to completion.
  • Ability to work in a detail-oriented environment.
  • Organizational Skills to prioritize multiple projects and tasks in a fast-paced environment.