Randstad Regulatory Affairs in Round Lake, Illinois

Regulatory Affairs

job details:

  • location:Round Lake, IL

  • salary:$50 - $60 per hour

  • date posted:Thursday, May 31, 2018

  • experience:0 years

  • job type:Contract

  • industry:Miscellaneous Manufacturing Industries

  • reference:140473

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...

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.