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
Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Intellectt Inc by 2x
See who you knowGet notified about new Regulatory Affairs Specialist jobs in Lake Forest, IL.
Sign in to create job alertSimilar jobs
People also viewed
-
Regulatory Affairs Compliance Specialist
Regulatory Affairs Compliance Specialist
-
Regulatory Affairs Associate
Regulatory Affairs Associate
-
Regulatory Affairs Associate
Regulatory Affairs Associate
-
Regulatory Affairs Associate
Regulatory Affairs Associate
-
Regulatory Affairs Specialist II - 3 Openings
Regulatory Affairs Specialist II - 3 Openings
-
Regulatory Affairs Specialist
Regulatory Affairs Specialist
-
Regulatory Affairs Specialist
Regulatory Affairs Specialist
-
Regulatory Affairs Specialist
Regulatory Affairs Specialist
-
Regulatory Affairs Associate
Regulatory Affairs Associate
-
Regulatory Affairs Specialist (249060)
Regulatory Affairs Specialist (249060)
Looking for a job?
Visit the Career Advice Hub to see tips on interviewing and resume writing.
View Career Advice Hub