Randstad Regulatory Affairs in Round Lake, Illinois
location:Round Lake, IL
salary:$50 - $60 per hour
date posted:Thursday, May 31, 2018
industry:Miscellaneous Manufacturing Industries
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
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
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.