Regulatory Affairs Manager

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.

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