Regulatory Affairs Specialist Job Listing at Kelly Services in Horsham, PA (Job ID 9572933)

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 Coordinator 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 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 (2) 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.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

 Apply on company website