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

• 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.
  
  

Education min. / Experience min: 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. 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.