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Regulatory Affairs Associate Jr
675 North Field Drive Mettawa, IL 60045 US
Job Description
*Depending on experience
• 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.
Confirm interview preferences (phone, onsite, video):
Initial interview via phone/video, 30 min. Then, select 2 or 3 candidates for an onsite interview.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The 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, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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