[itroundtable] LEAD: Position for Regulatory Affairs Manager - 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 Manager  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 – Fulltime / Permanent Job Description :  The Regulatory Affairs Manager is responsible for:          Ensuring that new LifeCell products and changes to existing LifeCell products are prepared and submitted in a timeline manner to Regulatory Agencies in all targeted markets          Interfacing with cross-functional development teams, Regulatory Agencies and distribution partners          Overseeing the work of entry level regulatory affairs personnel including training, mentoring and ensuring professional development   Primary Duties/Responsibilities:           Manages and develops regulatory staff          Responsible for oversight and prioritization of personnel tasks and projects          Prepares and supports regulatory submissions (510(k)s ,Dossiers, etc) in a timely manner meeting current regulations and guidance document requirements          Tracks and incorporates American Association of Tissue Bank Guidelines into filings          Ensures filings avoid conflicts between AATB and 21 CFR 1271 and appropriate international regulations          Primary contact and representative for all interactions with Regulatory Agencies for assigned projects          Participates on project teams representing Regulatory Affairs to provide inputs and answer questions related to regulatory requirements          Ensures regulatory milestones for assigned projects are met          Prepares regulatory strategies for medical devices and human tissue products to determine regulatory pathways to market including FDA "Letter to File" rationales for devices. Communicates regulatory strategy and updates, as necessary, depending upon new information generated during development          Reviews product labeling to assure compliance with regulatory requirements for medical devices and human tissue products          Review promotional material for human tissue products and medical devices to assure claims and indications are consistent with approved language/current product classifications          Ensures working knowledge of assigned products, including claims and associated requirements, in order to perform adequate reviews and compliance with standard operating procedures          Interprets and applies FDA and International regulations to business practices and provides regulatory input, advice and guidance to the organization          Monitors, tracks and actively assesses evolving FDA regulations, guidances, points-to-consider, warning letters and policies          Monitors current developments and potential changes and opportunities in the US and other regulatory jurisdictions   Qualifications: Position Qualification Requirements: Basic Qualifications:          Bachelor's Degree in Biological Science or related field          At least 5 years' experience in managing Regulatory Affairs in a healthcare environment          Experience with Microsoft Office applications including:  Word, Excel, & Outlook   Other Position Qualifications: In addition to the basic qualifications listed above, the following other position qualifications are required:          Experience working with FDA and International regulations, including but not limited to: 21 CFR 807, 21 CFR 820, ISO 13485, MDD 93/42/EEC, TGA Medical Device Regulations and SOR/98-282.          Experience filing submissions in the US and International markets, particularly medical devices.          Experience with regulatory Global devices          Experience managing functional groups in the development of relevant data to complete a regulatory submission          Demonstrated communication and presentation skills          Demonstrated attention to detail and organizational skills          Ability to lead a team, influence other and handle increasing levels of responsibilities          Ability to build relationships between Regulatory Affairs and other areas of the organization          Ability to oversee day-to-day performance of employees, organize a group and provide leadership          Ability to manage/supervise employees with ability to accomplish objectives          Knowledge of Human Cellular and Tissue Product regulations (21 CFR 1270/1271)    Preferred Qualifications: In addition to the basic qualifications and other required qualifications listed above, the following preferred qualifications also exist:          Certifications such as ASQ and Six Sigma          RAC (US) certification          Member of RAPS (Regulatory Affairs Professional Society)   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.