Jr Regulatory Affairs Specialist
Jr Regulatory Affairs Specialist
Intellectt Inc
Lake Forest, IL
See who Intellectt Inc has hired for this role
Role: Jr. Regulatory Affairs Associate
Location: Lake Forest, IL - 60045
Duration: 7 Months
Shift Timings: 8 am to 5 pm
Job Description
Years’ Experience: 1+ years’ experience in a medical device or similarly regulated industry
Duties
BS in engineering or scientific degree / 1+ years experience in a medical device or similarly regulated industry.
Top 5 Skills/requirements
Location: Lake Forest, IL - 60045
Duration: 7 Months
Shift Timings: 8 am to 5 pm
Job Description
Years’ Experience: 1+ years’ experience in a medical device or similarly regulated industry
Duties
- 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.
BS in engineering or scientific degree / 1+ years experience in a medical device or similarly regulated industry.
Top 5 Skills/requirements
- Strong analytical and problem-solving 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.
- Strong attention to detail.
- Good organizational / project management skills to manage and track a wide range of tasks;
- ability to develop realistic action plans as well as prioritizing work activities.
-
Seniority level
Associate -
Employment type
Contract -
Job function
Legal -
Industries
Biotechnology Research, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing
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