A Sr. Regulatory Affairs Specialist 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 the content, assembly, pre-final review, and filing of major medical device applications (e.g., IDEs, PMAs, 510(k)s) submitted to the FDA and foreign regulatory agencies. Additionally, you will be identifying and resolving quality issues as they present themselves. Moreover, you will apply regulatory expertise to the evaluation and solution of product development issues. Adecco Medical & Science is a division of the world leader in medical and scientific professional recruiting.
Sr. Regulatory Affairs Specialist 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
• Minimum five years’ of experience working in the Medical Device industry
• Experience developing, writing, and organizing all aspects of the IDE/PMA/510(k)'s and CE Submissions
• Ability to independently analyze and interpret novel clinical, medical and scientific data.
• Current knowledge of current U.S. FDA and global (Canada, Australia, European Union, Latin America, India, China, etc.) regulatory requirements within the medical device industry
• Excellent writing skills and the ability to write scientific summaries.
If you are interested in this Sr. Regulatory Affairs Specialist 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 email@example.com
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