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.
Company Description:We believe in people and their amazing potential. Whether you're looking for a job, seeking hires or thinking about working with us, you've come to the right place.
Finding highly skilled employees can be time consuming and costly. And trying to find a new job can be a frustrating experience.
We help people and businesses grow by matching the right talent to their needs, and building rewarding careers for the professionals we place.