Regulatory Affairs Associate
📋 Role Overview & Responsibilities
Description
Years 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
Duties: Manager regulatory submissions ot 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.
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 complimented - Similar skillset with a more regulatory or quality experience would be beneficial.
Note
Position is Fully onsite8am - 5pm
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This position is located in Lake Forest, IL with potential relocation and sponsorship assistance depending on candidate qualifications.
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