SHARE YOUR UPDATED RESUME AT *varun.j...@diverselynx.com* <varun.j...@diverselynx.com>
Dear Recruiter, Hope you are doing fine. We have an urgent requirement for *Regulatory Affairs Specialist at **Irvine*, *CA* for a *6- 12 months Contract* role. Please go through the same and let us know if you have anyone matching the below role. Please send your responses to *varun.j...@diverselynx.com* <varun.j...@diverselynx.com> with your candidate resume and contact details. SHARE YOUR UPDATED RESUME AT *varun.j...@diverselynx.com* <varun.j...@diverselynx.com> *Title* – Regulatory Affairs Specialist *Location* – Irvine, CA *Duration* – 6+ Months Contract SHARE YOUR UPDATED RESUME AT *varun.j...@diverselynx.com* <varun.j...@diverselynx.com> *Technical/Functional Skills* The Regulatory Affairs Specialist should provide direct World Wide Regulatory support to various projects and products. Candidate should support for strategic planning and product development efforts, provide Regulatory support for existing products with respect to product changes/modifications, labeling and promotional material review and approval. · Knowledge of FDA regulations and CE · Excellent communication skills, both verbal and written. · Good organizational skills. · Good analytical thinking, problem solving and investigative skills Additionally, experience supporting Japan, Russia, China, Brazil, Australia/New Zealand, and Canada are highly desirable. *Roles & Responsibilities* · Writes, coordinates and completes the submission of Regulatory documents to FDA and other Regulatory agencies (e.g. EPA). Includes international documents (e.g. tech files, etc.) · Prepares responses to FDA questions and other Regulatory correspondence · Provides direct Regulatory support to project teams including the creation of detailed Regulatory Plans · Includes in-depth team involvement including Core Team membership · Conducts product labeling and advertising review and approvals · Evaluates proposed product modifications for Regulatory impact. Completes Regulatory Assessments as needed · Other activities as assigned by supervisor including special projects, as needed · Perform other work-related duties as assigned by the manager of the role · 510(k)s and determinations as to whether a device modification may trigger the need for a new 510(k) · European Technical Files, including maintenance and change assessments. Thanks and Regards, Varun Jain Diverse Lynx LLC Email is the best way to reach me… Phone: 732-452-1006 ext 288 Fax: 732-452-0684 Email – *varun.j...@diverselynx.com* <varun.j...@diverselynx.com> *Linkedin - *https://www.linkedin.com/in/varun-jain-928487b9/ Diverse Lynx LLC |300 Alexander Park|Suite #200|Princeton , NJ 08540 “For our open jobs please visit Diverselynx Jobs <http://jobs.diverselynx.com/candidates/myjobs/searchjobsdone.jsp?a=9xjdnw687b7a7nvvdyut936kpjlgy0023blrozaecads0pdnwppcswnaaku8ji2g> ” “Note: Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, sex, age, national origin or disability. All applicants will be evaluated solely on the basis of their ability, competence, and performance of the essential functions of their positions. We promote and support a diverse workforce at all levels in the company. This is not an unsolicited mail. If it is not intended for you or you are not interested in receiving our e-mails please reply with a "remove" in the subject line and mention all the e-mail addresses to be removed with any e-mail addresses, which might be diverting the e-mails to you. We are extremely sorry if our email has caused any inconvenience to you.” -- You received this message because you are subscribed to the Google Groups "Oracle Users" group. To unsubscribe from this group and stop receiving emails from it, send an email to oracle-users+unsubscr...@googlegroups.com. To post to this group, send email to oracle-users@googlegroups.com. Visit this group at https://groups.google.com/group/oracle-users. For more options, visit https://groups.google.com/d/optout.
