Regulatory Specialist

1 month ago

Jacksonville, United States Kelly Science, Engineering, Technology & Telecom Full time

Kelly Science and Clinical FSP is currently seeking a Regulatory Specialist - Registration Lead for a long-term engagement in Jacksonville, FL with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.


Regulatory Specialist - Registration Lead

1) QUALIFICATIONS:

  • Minimum education required:
  • A Bachelor’s degree is required in a scientific field
  • Minimum experience (number of month/years and type of work experience beyond formal education) required for competent performance:
  • A minimum of 4 years of related Regulatory experience is required.
  • experience with medical device registration is required.
  • Excellent technical writing skills required.
  • Analytical thinking, problem solving, and investigative skills are required.
  • Experience in the application of Quality Management System Standard ISO 13485, MDD / MDR, and US FDA regulations
  • Demonstrable track record of successfully managing multiple projects simultaneously is required.
  • Excellent English written and oral communication skills are required.
  • Proficiency in Microsoft Office and all related applications is required.


2) SUPERVISION/AUTHORITY

  • Under general or minimum supervision, performs duties in terms of stated objectives.
  • JOB GOAL: Regulatory Specialist – International Registrations is responsible for generating and providing technical documentation to maintain global product registrations for EMEA, LATAM and ASPAC for a large-scale new product and lifecycle management project.


4) RESPONSIBILITIES:

  • Coordinate, compile, author, format and supply the required documentation (including the management of obtaining non-technical documents such as Certificates to Foreign Government, legalized/apostilled documents, etc.) to regulatory teams in Latin America, Asia Pacific, Japan and Europe, Middle East and Africa for product registrations.
  • Work with regulatory partners to ensure execution and approval of product registrations in accordance with project plans.
  • Researches, collects data, and addresses requests from local regulatory teams or regulatory agencies to prepare documentation required for health authority submissions
  • Work under minimal supervision, with benefit of previous regulatory experience.
  • Requires a general use and application of Regulatory concepts, practices and techniques.
  • Develop solutions to a variety of problems of moderate scope and complexity.
  • Perform other duties as assigned by the manager of this position

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