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Regulatory Affairs Specialist

Company: Kelly Services
Location: Warsaw
Posted on: September 21, 2022

Job Description:

Kelly Science and Clinical FSP is currently seeking a Regulatory Affairs Specialist for a long-term engagement 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. This Regulatory Affairs Specialist will help administer the day-to-day Regulatory Affairs operations as directed by the Associate Director related to Product Lifecycle Management (LCM), and Change Management for the China market. In addition, these jobs exhibit a degree of independent judgment and execute on plans that directly impact the operational results of the business.In this role, you will:

  • Lead and manage activities concerned with the submission and approval of joint reconstruction products to government regulatory agencies including the China NMPA.
  • Prepare, draft and file regulatory submissions to support product approvals for the China market.
  • Develop pragmatic strategies and implementation plans, establishes accountability for the preparation of regulatory submissions.
  • Interact with China RA personnel to expedite approval of pending application and to resolve regulatory matters.
  • Work independently to oversee multiple projects simultaneously and be responsible for contributing to developing regulatory strategies and project timelines.
  • Represent Regulatory Affairs on cross-functional project teams, and provide independent regulatory guidance to teams in strategic planning, product lifecycle, management, and the assessment of the impact product changes have on the status of regulatory licenses for the China market.
  • Plan schedules for regulatory deliverables on projects and monitors projects through completion.
  • Ensure adherence to standard operating procedures and protocol for the rapid and timely approval of regulatory support of marketed products.
  • Ensure organization compliance with all applicable regulations and J&J policies
  • Assist in the development of best practices for Regulatory Affairs processes. Leadership Competencies:
    • Connect by cultivating internal collaboration with the R&D, Med Affairs, Clinical Affairs, Marketing and the China RA team.
    • Deliver results for on-time clearances and approvals with a global and enterprise-wide mind-set and balance with strategic and short-term goals
    • Connect by encouraging and supporting internal collaboration across levels, creating effective solutions. Requirements
      • A minimum of a BA/BS is required. Equivalent work experience will be considered for the right applicant.
      • A minimum of three (3) years of relevant/regulated industry experience is required.
      • The ability to manage multiple priorities and work independently is required.
      • Previous experience with medical device regulations is preferred
      • Experience with the preparation, submissions and approval for Class II and III medical devices in China is preferred.
      • Strong problem-solving skills
      • Demonstrated ability to collaborate across functional and geographic boundaries is preferred. #P2

Keywords: Kelly Services, South Bend , Regulatory Affairs Specialist, Other , Warsaw, Indiana

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