Regulatory Affairs
Role: Regulatory Affairs Associate Jr
Location: Lake Forest, IL - 60045
Duration: 11 Months
Description
Experience: 1+ years’ experience in a medical device or similarly regulated industry Skills: Ability to schedule and organize multiple projects
Education: BS Engineering or Scientific degree.
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 product and procedures comply with applicable regulatory agency requirements and guidelines.
Position is Fully onsite brief synopsis
Top 5 Skills/requirements
Location: Lake Forest, IL - 60045
Duration: 11 Months
Description
Experience: 1+ years’ experience in a medical device or similarly regulated industry Skills: Ability to schedule and organize multiple projects
Education: BS Engineering or Scientific degree.
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 product and procedures comply with applicable regulatory agency requirements and guidelines.
Position is Fully onsite brief synopsis
- 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.
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. What skillset will compliment - Similar skillset with a more regulatory or quality experience would be beneficial. Confirm interview preferences (phone, onsite, video): Initial interview via phone/video, 30 min. Then, select 2 or 3 candidates for an onsite interview.
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Seniority level
Mid-Senior level -
Employment type
Contract -
Job function
Legal -
Industries
Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing
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