Regulatory Affairs

  • location: Round Lake, IL
  • type: Contract
  • salary: $50 - $60 per hour

job description

Regulatory Affairs

Contract position: Large medical device manufacturer has an immediate need in Regulatory Affairs Manager in Round Lake IL. This is a contract position expected to last 8 months, extension is likely, possible temp to perm. Currently we are only looking for local candidates. Great Contractor Benefits! Apply Now! Will hire ASAP!

Responsibilities for the Regulatory Affairs

  • Responsible for defining regulatory strategies and submissions in support of new and existing marketing authorizations for products for one or more business units/countries
  • Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations
  • Represent or lead the RA function on assigned cross-functional project teams
  • Monitor applicable regulatory requirements; assure compliance
  • Establish appropriate communication within RA and other functions primarily at project level
  • Perform gap analysis and propose solutions
Requirements for the Regulatory Affairs

  • BS degree
  • 5+ years in a regulated environment and experience with US Drug Submissions
  • Change Control in US Drug Products including assessment and analysis
  • Submission to FDA including prior approval, Changes Being Efficient (CBE)
  • Technical skills: Documentum, SharePoint, Word, Excel, PowerPoint, Outlook
Benefits

  • Paid Vacation
  • 401K
  • Health Insurance, and more...

get jobs in your inbox.

sign up
{{returnMsg}}

related jobs

    Regulatory

  • location: Deerfield, IL
  • job type: Contract
  • salary: $45 - $50.53 per hour
  • date posted: 6/20/2018

    Regulatory

  • location: Round Lake, IL
  • job type: Contract
  • salary: $51 - $60.15 per hour
  • date posted: 3/1/2018

    Clinical Operations

  • location: North Chicago, IL
  • job type: Contract
  • salary: $21 - $23 per hour
  • date posted: 5/1/2018