Senior Regulatory Affairs Associate in Chicago, IL

Senior Regulatory Affairs Associate

(Chicago Area, IL)

Summary:

This position is ideal for Ideal for someone looking to lead Regulatory strategy at the company’s facility located in the Chicago area.

This Regulatory Affairs Professional will be responsible for:

Development/Revision of 510k, regulatory filings and documentation processes including technical files
Letters/justifications to file, PMA supplements, and annual reports
International regulatory guidance’s and corresponding documentation
Regulatory guidance to research and operations staff
Device labeling and advertising input
Product and manufacturing change assessment
Regulatory support of Protocols and reports
Product complaints and management of reported adverse events and recalls
Communicate and coordinate regulatory activities with other departments to include
- Design control
- Risk assessment
- Design and process validation
- Regulatory assessments for Design History Files
Other duties as required

Requirements:

BS in science related field required
3 years of medical device or biological sciences field is preferred
Involvement in the process of Regulatory submissions requirements and terminologies
Excellent organizational and project management skills with strong attention to detail
Regulatory Certification a plus