Hi Friends, Hope you are doing great,
I have an urgent requirement from one of my esteem client, I will appreciate if you can have an eye on the below requirement and send me your consultant updated profile ASAP. *Job Title: Regulatory Associate / Regulatory Product Specialist* *Location: Chelmsford, MA / Morrisville, NC * *Duration: Long Term Contract* *Job Description:* • Review and understand gap assessments on Technical Files and Design Dossiers against MDR requirements. Review all technical documentation, including, but not limited to, design verification & validation protocols & reports, risk management files, usability protocols & reports, manufacturing process information, biocompatibility evaluation reports, list of applicable standards, list of general safety and performance requirements, declaration of conformity, and clinical data. • Support the collection and provision of data required to submit to EUDAMED. • Participate in regulatory impact assessments as it relates to the MDR and relay the information to product specific RA team member and/or design teams. • Identify use of appropriate International standards. • Bring MDR Regulatory Affairs questions/issues to the attention of MDR Project Management team and Business Units leads. • Determine issues which may create regulatory obstacles; investigate and propose solutions • May serve as MDR RA team member for promotional materials review and product labeling as they relate to MDR registration and commercialization of medical devices. • May support new product development teams to assure collection of appropriate data for MDR regulatory submissions and compliance. • Adhere to and ensure the compliance of Teleflex's Code of Ethics, all Company policies, rules, procedures and housekeeping standards.• Strong regulatory, cGMP, QSR, ISO knowledge base.. *Education / Experience Requirements* • Minimum of a Bachelor's degree required. Degree in a scientific discipline such as biology, microbiology, chemistry, engineering, or medical technology preferred. • Minimum of 5 years experience in Regulatory Affairs. • Minimum of 5 years experience working in a FDA or ISO regulated environment. • Experienced in the skillful preparation of technical files and design dossiers Thanks & Regards, Sai Kiran Nandrolu Sr. Recruiter W: (972) 393-2255 E: saikiran.nandr...@w3global.com A: 1701 Legacy Dr, Suite#1000, Frisco, Texas - 75034 -- Are you =EXP(E:RT) or =NOT(EXP(E:RT)) in Excel? And do you wanna be? It’s =TIME(2,DO:IT,N:OW) ! Join official Facebook page of this forum @ https://www.facebook.com/discussexcel FORUM RULES 1) Use concise, accurate thread titles. Poor thread titles, like Please Help, Urgent, Need Help, Formula Problem, Code Problem, and Need Advice will not get quick attention or may not be answered. 2) Don't post a question in the thread of another member. 3) Don't post questions regarding breaking or bypassing any security measure. 4) Acknowledge the responses you receive, good or bad. 5) Jobs posting is not allowed. 6) Sharing copyrighted material and their links is not allowed. NOTE : Don't ever post confidential data in a workbook. Forum owners and members are not responsible for any loss. --- You received this message because you are subscribed to the Google Groups "MS EXCEL AND VBA MACROS" group. To unsubscribe from this group and stop receiving emails from it, send an email to excel-macros+unsubscr...@googlegroups.com. To view this discussion on the web visit https://groups.google.com/d/msgid/excel-macros/CAGquW%2BLfbei_%3DBSHQrexVchAHsn553ckxTNfq%2BwAPsTeP_RG6A%40mail.gmail.com.
