US, US, CA - San Diego
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: No travel required
Location: CA - San Diego
Performs the coordination and preparation of document packages for regulatory submissions for new and mature products for domestic and international markets.
Execute regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards.
Prepare or assist in the preparation of international submissions for medical devices. Maintain proficiency on regulatory requirements.
Under the direction of the department manager, manage the generation of documentation to be submitted to worldwide governmental regulatory agencies in order to secure approvals to market products manufactured and/or distributed by third-party distributors.Work with cross-functional team members to successfully execute strategy for new product development projects.
Instill and drive a regulatory culture.
Provide continuing support of on-market product and associated manufacturing process changes by assessing their impact on product registrations/licenses, communicating the impact to the organization and gaining approval for those changes.
Review labeling, advertising, and promotional materials to assure conformation with international labeling requirements.
Must be cooperative and work well with all functional groups.
Responsible for communicating business related issues or opportunities to next management level.
Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485.