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| 560566-Global Regulatory Leade MD 55 - 118k (J#13316) Education: Bachelors Degree Experience: 10 - 20 years Essential Functions (Responsibilities): The Global Regulatory Leader for the ensures full regulatory compliance for Maternal & Infant Care (MIC) products globally. * Prepare and submit regulatory documents for US clearance (i.e. 510(k), PMA) * Prepare and submit regulatory documents for Canada clearance (i.e. License) * Prepare and submit regulatory documents for EU clearance (i.e. Tech Dossier) * Prepare and submit regulatory documents to in-country regulatory specialists (Asia) * Perform & participate in internal audits & regulatory inspections, as needed * Key core team member on product development teams * Ensure regulatory requirements are considered and incorporated as necessary into development programs * Oversee development of submission content and provide guidance to teams * Prepare responses to questions and comments from regulatory agencies * Interpret regulatory requirements for existing products * Provide written strategies to document regulatory decisions * Review post market design changes for regulatory impact * Review and approve changes made post approval to labeling, promotional advertising and technical information for appropriateness and accuracy of claims and instructions for use * Review product transfers for regulatory impact Qualifications/Requirements: *A Minimum 4 years BS in Biology, Chemistry, Information Technology or Engineering, or Medical Device Technology (or High School diploma/GED and 10+ years of professional experience in Regulatory Affairs in a regulated medical industry) * Minimum 7 years of professional experience in Regulatory Affairs in a regulated medical industry. * Previous experience working with ISO 9000 and/or FDA Quality System Requirements * Prior experience preparing 510k submissions * Must be 18 years or older * Must submit application for employment via www.gecareers.com (external candidate) or GE Career opportunity Systems (internal candidate) * For external candidates, must be willing to take a pre-employment drug test and submit to a background investigation as part of the selection process. Desired: * Advanced degree; medical product knowledge *RAC professional certification * Previous internal/external auditing experience * Excellent team player skills and global mindset * Excellent communication and interfacing skills * Good awareness of international regulations (Europe & Asia-Pacific) * Ability to work effectively under minimum supervision * A passion for effective process * Flexible in a changing work environment * High energy & execution focus General: Clinical Systems - Maternal Infant Care is a $150M business growing at double-digit rates globally, supporting life from its earliest moments. This is a great opportunity for a sole contributor to learn about the Maternal Infant Care business at the Headquarters located in Laurel, MD. Join our team to help us grow to $300M by 2008! GE is an equal opportunity employer. There are 2 Global Regulatory Leader positions open in Laurel, Maryland | |||
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