Regulatory Affairs Associate - Lake Forest, United States - Collabera
Description
Job Description
Job Description· 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 skill-set will compliment - Similar skill-set with a more regulatory or quality experience would be beneficial.
Company DescriptionCollabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.