Description
POSITION SUMMARY:Responsible for preparing FDA submissions and handling related interactions with FDA in accordance with departmental guidelines. Familiar with standard concepts, practices, and procedures within FDA-regulated industry. Assist with developing and/or improving standard procedures, and review and update of device labeling and marketing collateral. Responsible for post-market regulatory activities such as preparing periodic reports.
RESPONSIBILITIES:
* Prepare FDA submissions, including original PMAs, PMA Supplements, Annual reports, IDEs and 510(k)s
* Support timely approval of premarket submissions by understanding current FDA regulations and interpretation regarding medical devices and how these apply to company products, staying current on company product use and features, and researching competitive product approvals
* Review and prepare device design, software, and process verification and validation documentation for FDA submissions
* Prepare and update technical manuals and other product labeling as necessary to comply with FDA requirements; review labeling generated for compliance with FDA and company requirements
* Work closely with international Regulatory Affairs counterparts (in Germany and/or Switzerland) and other US departments to develop and implement regulatory submissions strategies.
REQUIREMENTS:
* Bachelor's degree in science or engineering
* 3-5 years of medical device regulatory affairs experience
* Ability to work independently and as part of a team
* Excellent computer skills, knowledge of Microsoft Office package, Windows and e-mail systems
* Excellent communication skills and the ability to work with all levels of the company
* Strong organizational skills and attention to detail.
To find out more about Real please visit www.realstaffing.com