[itroundtable] LEAD: Position for Regulatory Affairs - Bridgewater NJ

Please contact Keyur directly [Keyur.Patel@cyberThink.com] and let him know that I sent you. Ann Bergquist http://www.linkedin.com/in/annbergquist Our client is looking for Regulatory Affairs to join their Bridgewater NJ office.   If you are not looking then pls. forward it to your network who is looking for new opportunity.   No. of positions – 2 Location – Bridgewater, NJ Duration – 6+ months (High chance of becoming a fulltime OR being extended Job Description : Looking for a regulatory associate who has between 5 to 10 years' experience in the following: ·         Experience in preparing FDA IDE, FDA PMA, 510(k), BLA, NDA submissions ·         Knowledge of medical device directives and regulations including labeling for international submissions to KFDA, ASPAC/Japan/India/China, TGA, Health Canada, Chile, EMEA/EU Knowledge of FDA, EU and AATB regulations. ·         Experience in the review of promotional material and marketing and advertisement literature with respect to off label and on label attributes. ·         Knowledge of Global Operations and manufacturing including and new products development teams through a complete lifecycle with respect to medical devices and human tissue. ·         Knowledge of QSR, design control & design transfer with data-driven statistical input and correlating FDA regulations with ISO, AAMI, and IEEE. ·         Experience with internal mock QSR audits & external audits of suppliers to ensure compliance with FDA/ISO.   Please provide the following details along with your updated resume in word format…. Availability for an interview: Availability for start: Contact number: Best time to call you: Current location: Currently on project: If NO, then when was your last assignment ended: Reason for ending last assignment / Reason for searching a new job: Expected hourly rate on W2 no benefits basis:: Work authorization status in USA: Is commute feasible for you on daily basis?         Keyur Patel cyberThink, Inc 1125 US Hwy 22, Suite 1 Bridgewater, NJ 08807 Phone: (908) 429-8008 ext. 354 Cell: 908-875-3692 Fax: (908) 429-8004 Email: keyur.patel@cyberthink.com Website: www.cyberThink.com   Gmail: keyur.p.patel@gmail.com Connect to me:   Click here to view current job openings.    ___________________________________________________________________________________________________________________________________________ cyberThink, Inc. is a Certified Minority-Owned Business (MBE) and has been recognized as one of the fastest growing IT Services and Staffing companies in the U.S. by INC. magazine, Deloitte & Touche and Purple Squirrel. cyberThink, Inc. is an Equal Opportunity Employer (EEO). The information contained in this e-mail message and any attachments thereto ('e-mail') is intended for the use of only the individual or entity named above. The information may be confidential and protected by, work product immunity or other legal rules. If the reader of this message is not the intended recipient, or an employee or agent responsible to deliver it to the intended recipient, you are notified that retention, dissemination, distribution or copying of this e-mail is strictly prohibited. If you have received this e-mail in error, please immediately notify us by telephone or by e-mail reply, and immediately and permanently delete this e-mail message and any attachments thereto. Thank you.