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15 days old

Regulatory Affairs Specialist

Kelly Services
Warsaw, IN 46582
_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_


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**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 worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits 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** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


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 Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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Posted: 2022-09-14 Expires: 2022-10-15

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Regulatory Affairs Specialist

Kelly Services
Warsaw, IN 46582

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