Regulatory Affairs Specialist

3 weeks ago


Alameda, United States Intellectt Inc Full time

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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