Prepare 510(k)'s, Design Dossiers, and STeDs to support worldwide registrations as necessary.
Responsible for interacting with regulatory authorities as necessary.
Assures that all submission documentation, record keeping and reporting meet inspection standards in accordance with regulatory requirements.
May prepare responses to worldwide health authorities for submitted applications.
Will stay abreast of all pertinent regulatory affairs issues.
Other responsibilities include providing regulatory support for currently marketed products, including the review and approval of engineering drawings, labeling, technical files, design history files, and engineering change orders.
A Bachelor's Degree in a scientific or technical discipline, with a minimum of 6 years direct Regulatory Affairs experience within the medical device field, is required.
Knowledge of medical devices is preferred.
The candidate must have a demonstrated aptitude for preparing and submitting 510(k)'s in addition to preparation of EU Design Dossiers/Technical Files is preferred.
Prior interaction with the FDA and Notified Bodies is preferred and other worldwide agencies preferred.
Experience working with cross-functional teams is required.
Candidate must have the ability to provide innovative solutions within the boundaries of regulation, have the ability to organize data and identify issues or gaps, and have the ability to effectively communicate in oral and written forms.