This is Narayana from Intellectt Inc. We have a requirement for Regulatory Affairs Associate for one of our Medical Device Client, If you or anyone you know is interested in this role, you can reach me at 732 769 3774 or drop your resume to my mail narayana@intellectt.com
Role: Jr. Regulatory Affairs Associate
Location: Lake Forest, IL - 60045
Shift Timings: 8 am to 5 pm
Job Description
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.
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.
Skills –
Demonstrated competency and working knowledge of Excel, Word, PowerPoint, SharePoint, and Teams.
Communicate effectively verbally and in writing.
Communicate with diverse audiences and personnel.
Write and edit technical documents.
Ability to work with people from various disciplines and cultures.
Good organizational / project management skills to manage and track a wide range of tasks
Education And Experience –
BS in engineering or scientific degree / 1+ years experience in a medical device or similarly regulated industry.
Similar skill set with a more regulatory or quality experience would be beneficial.
Interview -
Confirm interview preferences (phone, onsite, video): Initial interview via phone/video, 30 min.
Then, select 2 or 3 candidates for an onsite interview.
Seniority level
Associate
Employment type
Contract
Job function
Legal
Industries
Biotechnology Research, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing
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