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

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

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