Role Regulatory Affairs Specialist
Mandatory Technical Skills Experience interfacing with regulatory agencies (e.g. FDA, MHLW, Health Canada, KFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL. Regulatory Submission Desirable Technical Skills UDI , Unique Device Identifier , Medical Device , Class 1 , II , III medical devices , Regulatory Affairs Certification (RAPS) Mandatory Functional Skills Sound knowledge of UDI (Unique Device Identifier). Bachelor’s Degree (or international equivalent) in a related field such as: Regulatory Science, Biomedical Engineering, Biology, Chemistry, English (with a technical writing emphasis), Legal Studies, Law, Nursing, Physician Assistance, Pharmaceutical Science, Pharmacy OR minimum of 4 years progressive regulatory affairs experience in medical device or pharmaceutical industry or medical product regulation agencies, including knowledge and experience applying drug or device laws and regulations Desirable Functional Skills Understanding of healthcare environment & Regulatory Authorities , 501K submission procedure and documentation.Experience in a medical device or pharmaceutical industry. Total Experience Required 8+ Work Location Milwaukee , Wisconsin Duration 12-18 Months with Possibility of extension Regards, *Hemendra kumar* *hemendra.ku...@insigmainc.com* <hemendra.ku...@insigmainc.com> | tel. 703-468-3024 I YM. hem_rajpoot2012 ABOUT THIS E-MAIL: The information transmitted is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any review, retransmission, dissemination or other use of, or taking of any action in reliance upon, this information by persons or entities other than the intended recipient is prohibited. If you received this in error, please contact the sender and delete the material from any computer. -- You received this message because you are subscribed to the Google Groups "CorptoCorp" group. To unsubscribe from this group and stop receiving emails from it, send an email to corptocorp+unsubscr...@googlegroups.com. To post to this group, send email to corptocorp@googlegroups.com. Visit this group at http://groups.google.com/group/corptocorp. For more options, visit https://groups.google.com/d/optout.
