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Regulatory Affairs Associate Jr

Lincolnshire Woods, IL 60045

Posted: 04/18/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 605490 Is job remote?: No Country: United States

Job Description

• 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.

Years 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

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.

Pay ranges between $20-25/hr based on experience 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Lincolnshire Woods, IL

Ready to embark on a career adventure in the vibrant Lincolnshire Woods, Illinois area? This picturesque region nestled in Lake County offers a perfect blend of urban amenities and natural beauty. With renowned art galleries like the Robert T. Wright Community Gallery of Art, acclaimed theaters like the Marriott Theatre, and the nearby iconic Wrigley Field where you can catch baseball games, there's no shortage of cultural delights to explore. Imagine weekends spent hiking at Half Day Forest Preserve or indulging in the local cuisine at The Barn of Barrington. Embrace growth opportunities and a quality lifestyle in this charming locale by exploring our job listings today!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.