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: [email protected] A: 1701 Legacy Dr, Suite#1000, Frisco, Texas - 75034 -- You received this message because you are subscribed to the Google Groups "Android Developers" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To view this discussion on the web visit https://groups.google.com/d/msgid/android-developers/CAGquW%2BLfbei_%3DBSHQrexVchAHsn553ckxTNfq%2BwAPsTeP_RG6A%40mail.gmail.com.
