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26 days old

Regulatory Affairs Specialist

Kelly Services
Somerville, NJ 08876
Kelly Outsourcing & Consulting Group (KellyOCG), a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a Regulatory Affairs Specialist for a Project engagement at one of our Global clients in Somerville, NJ.


This role is a full-time, fully benefitted position. As a KellyOCG employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from. Youll also be eligible for paid time off, including holiday, vacation and sick/personal time. All KellyOCG employees receive annual performance reviews.


As a Regulatory Affairs Specialist placed with KellyOCG you will be responsible for the following: **OVERALL RESPONSIBILITIES:**


+ Review TRD against China YY/GB standards and specifications.

+ Identify any potential gaps and closely working with R&D and QA SME in resolving them if any.

+ Communicate with China RA and R&D/QA on TRD related requirements and remediation activities.

+ Work closely with China RA on questions from china NMPA for all China submissions related to TRD remediation, strategizing the appropriate response with SMEs and obtain the appropriate technical information needed.

+ Review documents for all China submissions related to TRD to ensure accuracy and consistency with TRD remediation

+ Attend TRD related meetings.

+ Assist in TRD tracking and monitoring for R&D and for China RA submission purpose.

+ Provide support for TRD resource & timeline estimation.

+ Provide timely update to MD TRD project PMO as needed

+ Review documents in China submissions related to TRD and provide feedback

+ Upload TRD related documents into documentation system


**EDUCATION & EXPERIENCE REQUIREMENTS:**


+ A minimum of a B.A./B.S., preferably within a technical or scientific related discipline, is required.

+ A minimun of 2-4 years of relevant / regulated industry experience is required.

+ Experience with medical devices is strongly preferred.

+ RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society, is a plus.


**Why Kelly** **** **?**


The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ) is one focus within the full array of Kelly Services workforce solutions.


Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.


The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.


**AboutKelly Services** ****


As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook (https://www.facebook.com/kellyservices) , LinkedIn (http://www.linkedin.com/company/kellyservices) and Twitter (https://twitter.com/kellyservices) .


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-09-29 Expires: 2021-10-30

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Regulatory Affairs Specialist

Kelly Services
Somerville, NJ 08876

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