Job Details

  • Title: Regulatory Affairs Associate Jr
  • Code: RCI-5559
  • Location: Des Plaines Illinois (IL) 60018
  • Posted Date: 10/08/2020
  • Duration: 13 Months
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  Job Description

Primary Function / Primary Goals / Objectives:

  • Provide full support to reporting manager in terms of content review, document fulfillment check, document preparation, filing support and archival of regulatory records.
  • Ensure product launch timelines are met.
  • Provide registration support to ensure timely launch of changes in products registered globally.
  • Ensure completeness of product registration dossiers according to product regulatory classification.
  • Prepare risk analysis and mitigation strategies of any new/upcoming requirements for business.
Major Responsibilities:
  • Daily follow-up on availability of documents and work on documentation availability timeline to ensure minimal impact on regulatory launch plan for new range of products.
  • Ensure regulatory project deadlines and performance standards are established and met.
  • Determine the scope of information/documentation necessary to file new registration applications and post-approval changes according to existing checklists to regulatory agencies.
  • Identify upcoming/evolving regulatory requirements for new IVD product launch.
  • Sensitize reporting manager with inputs on possible factors which may impact the regulatory launch plan timeline of new product line for AMD.
  • Compile and review regulatory submissions for timely registration of changes in products of entire range of on-market products for AMD.
  • Ensure product regulatory launch plan is strictly met.
  • Provide timely inputs to reporting manager in modifying product launch timeline with adequate time to implement same without any financial/resource constraints.
  • Work with reporting manager to maintain good contact and ensure timely follow-up with regulatory agencies.
  • Review product labeling material for compliance with applicable regulations and standards.
  • Work on instructions from reporting manager towards timely submission of products and project tracking.
  • Draft processes for new regulatory requirements towards effective implementation.
JOB SPECIFICATIONS:
  • Project Manager Skills
  • 2 years at minimum with a regulated industry. Strong knowledge of IVD or Medical device regulatory affairs
  • Minimum Skill, Education,
Experience 

Bachelor's degree in life sciences or pharmacy (Biochemistry, Biotechnology, Microbiology, Immunology, Medical technology, pharmacy, Pharmacology) is preferred.
  • Masters in above field will be preferred.
  • Knowledge on requirements of Global product registration.
  • Product knowledge on In-vitro diagnostics products will be preferred.
KEY REQUIREMENTS:

The opening will be a key part of the registration activities related with the legal entity name changes related.
The position will remain strongly accountable for deliverables set by reporting manager or management from time to time towards successful implementation of this change globally for AMD.