Regulatory Affairs Specialist / Medical Devices
Location: Somerville New Jersey
Description: Pioneer Data Systems is currently seeking to employ Regulatory Affairs Specialist / Medical Devices right now, this occupation will be placed in New Jersey. For complete informations about this occupation opportunity kindly read the description below. Job Description: The Regulatory Affairs Specialist is responsible for providing assistance for EU and global p! roduct submissions&renewal for the Global Surgery Group’s Center of Excellence and for ensuring product registration/submission are in compliance with applicable regulations and standards to ensure timely global commercialization of products With moderate supervision the Regulatory Specialist will be responsible for the following Regulatory activities: Prepare, review and issue documentations to support global product registrations and design dossier renewals. Prepare, review and issue Technical Files when needed product registrations. Assist in develop and implement regulatory strategies and processes to ensure timely global commercialization of products in compliance with applicable regulations and standards. Assist in evaluate proposed changes to product design or manufacturing processes and assess impact of the proposed changes with regard to worldwide approvals and internal Ethicon policies and procedures. Communicate issues or opportunities related to global product! registrations to next management level. Ensure personal and C! ompany compliance with all Federal, State, local and Company regulations, policies, and procedures. Perform other duties assigned as needed.
Qualifications Bachelor’s Degree in a scientific or technical field required. 2-5 years of experience in Regulatory affairs required, preferably medical devices.
Additional Requirements: Must be familiar with MS Office applications Excellent communication skills (verbal and written) Project management skills Problem solving skills Presentation skills
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If you were eligible to this occupation, please email us your resume, with salary requirements and a resume to Pioneer Data Systems.
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This occupation starts available on: Fri, 15 Nov 2013 18:06:39 GMT