Regulatory Affairs Specialist
Company: Kelly Services
Posted on: September 21, 2022
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
- 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
- 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
- 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
- Deliver results for on-time clearances and approvals with a
global and enterprise-wide mind-set and balance with strategic and
- 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
- 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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