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10 days old

Regulatory Affairs Specialist - China TRD Project

Kelly Services
Somerville, NJ 08876
Kelly Services Outsourcing & Consulting Group is seeking a Regulatory Affairs Specialist in Somerville, NJ to support a China Technical Requirement Document (TRD) project. This is a long-term, open-ended assignment with benefits! The Regulatory Affairs Specialist is responsible for managing regulatory activities such as RA reviews, tracking of files, communications between R&D team and China RA team, and approvals and document control activities for these files.





The Regulatory Afairs Specialist is responsible for but not limited to:




+ Review TRD against China YY/GB standards and Customer specifications. Identify any potential gaps and if any, closely work with R&D and QA SME in resolving

+ 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 remediations, 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 Customer 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 the documentation system





**REQUIRED EDUCATION, TRAINING and/or EXPERIENCE:**




+ Bachelors Degree required, preferably in scientific or technical field

+ 4-6 years of experience working within a highly regulated environment, preferably medical devices, 1-3 years of direct regulatory experience required.

+ Must have working knowledge of U.S., E.U., and International Regulatory requirements and be able to apply this knowledge to ensure that all projects maintain compliance to worldwide regulatory requirements.

+ Must have previous experience with document management systems and change control systems.

+ Must be able to work independently, utilizing research and problem-solving skills, and the willingness to learn new skills.

+ Must have excellent global written, verbal communication and presentation skills.

+ Must be able to communicate clearly, succinctly and effectively.

+ Must have solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive.

+ Must be able to work in a timeline-driven environment.





**REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:**




+ Bachelors degree required, science or technical area preferred




+ Working knowledge of MS Office programs (Word, Excel, PowerPoint, Outlook) and databases

+ Familiarity with Adobe Acrobat Professional and electronic document management systems

+ Participation in conference calls and meetings during night/early mornings may be required at times

+ Someone who speaks Chinese is highly preferred



Please note - This is a BYOD position, requiring candidates bring their own device/laptop.



If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!



**This position comes with enhanced benefits which include:**




+ 50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)*

+ Paid sick days and vacation days*





**Perks of being a Kelly employee:**




+ Weekly electronic pay

+ Access to more than 3,000 online training courses though Kelly Learning center

+ Online application system

+ Never an applicant fee





*benefits to be received upon meeting eligibility requirements





**Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume.**






**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 , LinkedIn and Twitter .


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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2019-11-04 Expires: 2019-12-09

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Regulatory Affairs Specialist - China TRD Project

Kelly Services
Somerville, NJ 08876

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