Education and/or Experience:

• Bachelor’s degree in science or health related discipline (advanced degree preferred)


• Minimum of 3-5 years of professional experience of medical devices with relevant Regulatory Systems ownership/management or IT experience (such as SFDC, Document Management systems, Qlikview and SAP).


• People Management experience required


• Regulatory eCTD/510(K)/PMA publishing knowledge and experience.


• Knowledge of U.S. and international regulations including cGMP, GCP, GLP, ICH guidance documents.


• Knowledge and understanding of global regulatory submission formats, industry standards, guidelines, validation concepts, and publishing best practices including eCTD/510K format and registration tracking.


• Ability to work with high level contacts and exposure to sensitive information necessitating considerable use of tact, diplomacy, discretion and judgment.


• Detail-oriented with the ability to promptly assess documents and data for accuracy as well as consistency


• Strong interpersonal skills with the ability to influence others in a positive and effective manner


• Strong team and customer focus


• Working knowledge of medical device and IVD development, approval process and life-cycle


• Excellent communication skills; both oral and written


• Prior experience in developing and maintaining medical device and IVD documents throughout their lifecycle.


• Broad knowledge of the med tech industry.


• Demonstrated ability to contribute to a continuous learning and process improvement environment.