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Regulatory Consultant job in Gainesville, FL
Medical & Science
Regulatory Consultant needed in Gainesville, Florida area for a contract as a Regulatory Consultant
Adecco Medical & Science is seeking candidates eith experience in Regulatory processes for medical devices.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required:• Bachelors of Science degree in a technical or business discipline. • Minimum of 5 years of experience in a medically regulated and technical environment with at least five years in a medical device company (FDA Class I or II equivalent – Class III a plus). • Must have experience with successful preparation and submission of 510(k), PMA, or international documents or registration and marketing of medical device worldwide. • Experienced in design control process • Strong working knowledge of medical device regulations (21CFR) and FDA law • Passion for research • Experience in supporting international registrations desirable. • Certified regulatory affairs professional would be desirable..
• Preparation, submission and prosecution of regulatory submissions to the FDA and other regulatory agencies. Our expertise includes many successful 510(k) submissions.
• CE Mark Technical Dossiers: We can provide a range of support from review to full authorship.
• Perform literature review for regulatory compliance.
• Support World Wide Registration activities for product
• Work closely with Marketing and Quality on localization activities
• Quality Systems Implementation: We can develop and implement a quality system that is fully compliant with the FDA QSR and the ISO12485 standard or we can review and recommend changes to bring your current Quality System into compliance.
• Support IDE product development
• Regulatory Strategy: Advice regarding the appropriate regulatory strategies for U.S. and international device.
If you are interested in this Regulatory Consultant job opportunity in Gainesville, Florida then please click APPLY NOW. For other opportunities available at Adecco Medical & Sciencego to www.adeccousa.com. If you have questions about the position please contact Debi Bowles at 866-271-3454 or email@example.com
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
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