Regulatory and Quality Administrator in Franklin, IN at Volt

Date Posted: 5/10/2018

Job Snapshot

  • Employee Type:
    Contingent
  • Location:
    Franklin, IN
  • Duration:
    24 weeks
  • Date Posted:
    5/10/2018
  • Job ID:
    114304
  • Pay Rate
    $30.0 - $40.0/Hour
  • Contact Name
    Volt Branch

Job Description

Position: Regulatory and Quality Administrator

Location: Franklin, IN

Status: 6-month contract

Job Description

Assist in maintaining the Regulatory/Quality systems to meet FDA, ISO13485, CE, Health Canada and other foreign regulatory bodies’ compliance. Ensure customers outside the U.S meet regulatory compliance to purchase our products.

Essential Duties:

  • Prepares, and coordinates customer regulatory submissions and ensures submissions are completed within defined time schedules and meets customer requirements.  This includes Certificates to Foreign Government and other regulatory letters or documents, or provision of Technical File information.
  • Monitor and coordinate company regulatory licenses and registrations and ensures renewals or updates are completed within defined time schedules and within regulatory requirements.
  • Coordinates company internal audit program to ensure audits occur in accordance with regulatory requirements, and ensure completed documentation is retained on file.
  • Completes internal audits to ensure regulatory compliance.
  • Maintain and update the company Training Matrix, including identification to Management of initial training requirements and working with Management to ensure there are no training gaps.
  • Coordinate and track the company Corrective and Preventative Action program to ensure actions are documented and completed in accordance with defined timelines.
  • Create, revise, and review documentation required to meet the requirements of the company Quality Management System.
  • Make necessary changes to forms and work instructions as dictated by management
  • Organize the routing of documents throughout the document control process from creation, approvals, and distribution to filing.
  • Maintain the master copy of documents with revisions, master document list and records retention listings.
  • File and organize all Point of Use binders for all areas.
  • Assist Supervisors and Managers with distributing training records, and collating training information for input into the company Training Matrix.
  • Train staff on document control processes and documentation.
  • Effectively communicate with employees with varying levels of comprehension or with limited English language skills
  • Aid in document preparation and retrieval during regulatory audits

Requirements:

  • Bachelor’s degree and 3-5 years of experience in a related field.
  • Ability to communicate effectively in written and verbal English
  • Excellent proficiency with Microsoft Word, Excel, Power Point and Outlook
  • Must be willing to work overtime when needed
  • Medical Device Regulatory compliance
  • Project management
  • Document Control
  • Organization and attention to detail

Please apply to position or contact Sondeep "Sunny" Singh at (317) 685-2200 for any questions and more details regarding this position.

Volt has been serving some of the nation's strongest companies for over 60 years. As a Volt employee, you can expect the highest level of on-site support. We have a long-standing tradition of developing lasting and mutually beneficial relationships with its employees.

Volt is an Equal Opportunity Employer