Regulatory Affairs Specialist
3 weeks ago
Role: Regulatory Affairs Associate
Location: Alameda, CA
Duration: 10+ Months
Shift Timings: 8 am to 5 pm
Job Description:
· Experience in a medical device or similarly regulated industry
· Ability to schedule and organize multiple projects
· BS Engineering or Scientific
· 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.
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.
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