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Director of Regulatory Affairs job in Valencia, CA
Director of Regulatory Affairs
A Director of Regulatory Affairs job opportunity needs to be filled immediately by Adecco Medical & Science. This is a direct hire opportunity in Valencia, CA. You will be responsible for developing global regulatory strategies and submissions to ensure compliance and approval from the FDA. Additionally, you will advise on regulatory requirements, prepare submissions, negotiate their approval, and assure compliance. Moreover, you must be able to function in a start-up like environment and be hands-on. Adecco Medical & Science is a division of the world leader in medical and scientific professional recruiting.
Director of Regulatory Affairs job responsibilities:
• Draft, assemble, and file original documentation and submission materials for new or existing products to regulatory authorities.
• Ensure that all submissions are accurate and well supported by literature and regulatory foundations.
• Draft and/or compile supporting documentation related to such applications and manage any related activities by third parties.
• Interface with clinical research organizations and/or in-house clinical research associates in drafting/assembling regulatory materials.
• Track submissions, initiating internal communications and activities to adequately respond to agency inquiries and requests.
• Bachelor’s or Master’s Degree in Biology, Chemistry or other relevant Life Sciences related field
• 10+ years of global experience in successful regulatory affairs leadership in the medical device industry
• Experience directing multiple regulatory submissions, including generating regulatory documents to the FDA, EU and other applicable international authorities for approvals, responses and inspections
• Must have experience with Class II/III medical device
• Experience managing, preparing and submitting original PMA, PMA Supplement and 510(k) applications and received FDA approval
• Ability to work and partner with study statisticians during various stages of FDA submissions
• Review of clinical study protocols
• Experience managing complaint tracking, creating and writing SOP's, controlling and releasing documents
• Experience implementing design controls, including knowledge of product design and manufacturing
• Detail-oriented with strong organizational skills and the ability to prioritize multiple tasks/projects
• Willing to travel both domestically and internationally
If you are interested in this Director of Regulatory Affairs job in Valencia, CA then please click APPLY NOW. For other opportunities available at Adecco Medical and Science go to www.adeccousa.com or email your resume to firstname.lastname@example.org
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