Jr. Regulatory Affairs Associate
Role: Jr.Regulatory Affairs Associate
Location: Lake Forest, IL - 60045
Duration: 10+ Months
Description
Experience: 1+ years experience in a medical device or similarly regulated industrySkills: Ability to schedule and organize multiple projectsEducation: BS Engineering or ScientificDuties: 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.
Position is Fully onsite brief synopsis -
Location: Lake Forest, IL - 60045
Duration: 10+ Months
Description
Experience: 1+ years experience in a medical device or similarly regulated industrySkills: Ability to schedule and organize multiple projectsEducation: BS Engineering or ScientificDuties: 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.
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 complimented - Similar skillset with a more regulatory or quality experience would be beneficial.
-
Seniority level
Associate -
Employment type
Full-time -
Job function
Legal -
Industries
Staffing and Recruiting
Referrals increase your chances of interviewing at Intellectt Inc by 2x
See who you knowGet notified about new Regulatory Affairs Associate jobs in Lake Forest, IL.
Sign in to create job alertSimilar Searches
Looking for a job?
Visit the Career Advice Hub to see tips on interviewing and resume writing.
View Career Advice Hub