Sr Regulatory Affairs Associate

Sunrise, FL 33325

Posted: 08/19/2018 Industry: Professional Services Job Number: a4a7901b-bb79-45dd-8314-7b4471bc11e7 Pay Rate: 70000 - 72000
Develop medical device regulatory submissions in accordance with FDA requirements (e.G., pre-submissions, original IDEs, IDE supplements, 6-month Investigator Lists, original PMAs, PMA supplements, IDE/PMA Annual Progress Reports, 510(k)s, MAFs)
Develop Design Dossiers and Technical Files for CE marking purposes
Develop other international regulatory submissions as required
Review and approve proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
Review and analyze technical protocols, data, and reports generated by Research and Development, Operations, Clinical Research, Quality Assurance or other related departments.
Participate in the development of world-wide regulatory strategies to ensure rapid and timely approval of devices and continued regulatory support of marketed devices and other products.
Partner with cross functional teams by providing independent regulatory guidance and support to product development teams for strategic planning, design and development, and compliance activities.
Develop procedures to ensure regulatory compliance
Respond to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals in other countries, as well as provide routine regulatory information to associates and affiliates.
Review and provide regulatory authorization for Nonconformance reports (NCR)
Provide Regulatory Affairs support during internal and external audits.
Prepare and file facility registration documents
Conduct external audit activities as requested
Prepare the necessary documents to obtain Certificates of Exportability and Certificates to Foreign Government from US FDA
Manage commercial device tracking
Develop clinical protocols and clinical study reports
Prepare and submit medical device reports
Perform various other duties as assigned

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