DivIHN (pronounced "divine") is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.
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For further inquiries regarding the following opportunity, please contact one of our Talent Specialists
Rashi at
Title: Regulatory Affairs Associate Jr
Location: Lake Forest, IL
Duration: 7 Months
Description
Exempt/Non Exempt: Non exemptYears.
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.
Manager is Insun Ho Start date will be determined when candidate is identified.
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.
Ability to schedule and organize multiple projects
What skillset will complimented - Similar skillset with a more regulatory or quality experience would be beneficial.
Interview: Initial interview via phone/video, 30 min. Then, select 2 or 3 candidates for an onsite interview
About us:
DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.