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25 days old

Regulatory Affairs Associate

Kelly Services
Bridgewater, NJ 08807
Start the New Year with a new job! Kelly Services is seeking a Regulatory Affairs Specialist with International experience for a one-year assignment, with potential to extend, starting in January 2020. This position is based in Bridgewater, NJ and all work must be done onsite. The RA Specialist will provide Information and regulatory support to the International RA team members for product registrations, renewals, launches, etc. as well as the global regions on all US products across the customer and subsidiaries product portfolio so that regions can file products with the needed documentation and information for their submissions.





KEY ACTIVITIES/RESPONSIBILITIES



Responsible for providing Regulatory Affairs support to International RA teams for product registrations, renewals to global markets for all US approved/cleared products including pharmaceuticals, medical devices, nutritionals and skin care products.



Provide support for all requested documents (certificates/letters), search and retrieve product labeling & all needed support documentation.



With the oversight of Regulatory leadership, the incumbent will prepare and obtain Letter of Authorizations/Letter of Declaration/Power of Attorney Letters; Certificate of Free Sale from State of NJ/ CPP from Federal Agency (FDA); Notarized, Legalized, or Apostilled Regulatory Documents



Technical Inquiries and coordination (including manufacturing, process, raw materials, technical files)



Search and retrieve documents from RA system and tools and provide links to the international requestors (Sharepoint, Clinops, Liquent /Insight viewer) where information can be found.



Work with other International Support groups (Operations, QA, etc.) to provide assistance to regions.





QUALIFICATIONS/TRAINING



BS required, preferably in Biological Sciences



5 or more years of experience in Regulatory Affairs



Experience supporting global programs



Knowledge of regulatory guidelines for medical devices



Ability to work independently, as well as with a team



Adaptability/flexibility to support multiple products as needed



Proficient in MS Office, SharePoint





Although the position wont officially start until January, the manager is ready to review resumes and start interviewing. If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for consideration!





Perks of being a Kelly employee:



Weekly electronic pay



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



Group rate insurance options available immediate upon hire*



Service bonus plan and holiday pay*



Online application system



Never an applicant fee





*perks 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** **** **?**



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.




**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. 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 is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2019-10-25 Expires: 2019-12-14

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Regulatory Affairs Associate

Kelly Services
Bridgewater, NJ 08807

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