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
Requirements 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
- 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
- Health Insurance, and more...