Hi ,This is Harsha Vardhan from Intellectt Inc. one of our medical device client were looking for regulatory Affairs in IL if you are interested please share me your updated resume to harsha.v@intellett.com or give me a direct call at +1 732-276-1830
Role: Regulatory Affairs
Location: Lake Forest, IL - 60045 - 100% Onsite
Duration: 12 Months (Possible for Extension)
Shift Timings: 8 am to 5 pm
Responsibilities
- Supports execution of External Regulations Standards and Guidance Documents packages through tracking and monitoring ePAS packages from draft to final closure
- Prepares metrics associated with the process for Executive Management Review (EMR)
- Completes final signature approval of an ePAS package (i.e., FSG Approval)
- Data review, analysis, and verification.
- Manager regulatory submissions to ensure timely regulatory approval of medical devices.
- Monitor changing regulations in geographies and translate/communicate these requirements to project development and/or continuous improvement project teams.
- Ensure all client products and procedures comply with applicable regulatory agency requirements and guidelines.
Education / Experience
- BS in engineering or scientific degree
- 1-3 years experience in a medical device or similarly regulated industry
Skills
- Strong analytical and problem-solving skills.
- Demonstrated competency and working knowledge of Excel, Word, PowerPoint, SharePoint, and Teams.
- Communicate effectively verbally and in writing.
Interview