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.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Legal
Industries
Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing
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