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Senior Regulatory Affairs Specialist

Lake Zurich, Illinois

Post Date: 10/30/2017 Job ID: 1724 Job Category: Clinical: Regulatory

Responsible for establishing regulatory strategies for assigned product lines with appropriate supervisory approvals. Prepare submissions for assigned Automated Blood Technology projects world-wide. Responsible for on-time filing of high-quality regulatory submissions for new products, changes and compliance activities. Participate on multi-functional project teams and act as global regulatory advisor. Represent Regulatory on complex core teams. Able to operate independently with limited supervision.

Job Responsibilities:
  • Represent regulatory on assigned product and project teams and establish regulatory strategies that align with world-wide objectives.
  • Execute regulatory plans for complex projects. Develop and execute project plans for change control, new registrations and maintenance of existing licenses world-wide.
  • Keep apprised of global regulatory requirements and inform product teams of upcoming changes in the regulations.
  • Provide assistance with responses to regulatory agency questions.
  • Review and approve product labeling and advertising for compliance to applicable regulatory requirements.
  • Review technical documentation for suitability to support regulatory filings with regard to content, quality and clarity.
  • Act as regulatory project manager on assigned projects. Interact with subject matter experts to help ensure on-time, quality documentation for regulatory filing. Drive to expected regulatory timelines.
  • Provide regulatory expertise and technical knowledge to fulfill complex post-market requirements.
  • Act as liaison for Business Unit RA to Country RA interactions


Qualifications/ Requirements:
  • Experience in preparing and filing complete 510(k) applications to FDA
  • Thorough understanding of the CFR, FDA/ICH guidelines and cGMP’ s, as they pertain to medical devices.
  • Excellent communication and writing skills in the English language.
  • Proficiency in using Microsoft Office software tools including Word, Excel, and Powerpoint.
  • Ability to manage multiple projects and deadlines and communicate conflicts of priorities.
  • 5 years regulatory affairs or equivalent experience within a medical device/pharmaceutical company, CRO, or similar organization.
  • Bachelor’ s degree in a scientific discipline or engineering preferred.

 

Aaron Goldman
Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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