Job Description

-Develop medical device regulatory submissions in accordance with FDA requirements (e.g., pre-submissions, original IDEs, IDE supplements, 6-month Investigator Lists, original PMAs, PMA supplements, IDE/PMA Annual Progress Reports, 510(k)s, MAFs)

-Develop Design Dossiers and Technical Files for CE marking purposes

-Develop other international regulatory submissions as required

-Review and approve proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.

-Review, edit and provide regulatory and quality system approval for project documentation.

-Review and analyze technical protocols, data, and reports generated by Research and Development, Operations, Clinical Research, Quality Assurance or other related departments.

-Participate in the development of world-wide regulatory strategies to ensure rapid and timely approval of devices and continued regulatory support of marketed devices and other products.

-Partner with cross functional teams by providing independent regulatory guidance and support to product development teams for strategic planning, design and development, and compliance activities.

-Develop procedures to ensure regulatory compliance

-Act as an active regulatory representative on project teams

-Respond to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals in other countries, as well as provide routine regulatory information to associates and affiliates.

-Review and provide regulatory authorization for Nonconformance reports (NCR)

-Provide Regulatory Affairs support during internal and external audits.

-Prepare and file facility registration documents

-Conduct external audit activities as requested

-Prepare the necessary documents to obtain Certificates of Exportability and Certificates to Foreign Government from US FDA

-Manage commercial device tracking

-Develop clinical protocols and clinical study reports

-Prepare and submit medical device reports

-Perform various other duties as assigned

Qualifications

-Bachelor's degree in Science or Engineering (or related field) from an accredited college or university required. Minimum 5 years direct experience in regulatory affairs (preferably in the medical device/drug or biomedical area).

-Solid knowledge of US and European regulatory processes, including Class III is required.

-Practical (hands-on) experience in a medical device regulatory environment, preparing submissions (IDEs/IDE supplements, PMAs/PMA Supplements, 510(k)s and Design Dossiers/Technical files) for Class II and III medical devices and a successful track record is required.

-Experience interacting with U.S. FDA and European Notified Bodies is required.

-Experience presenting at FDA meetings is preferred.

-Sound knowledge and understanding of how IDE-regulated clinical studies are performed is required.

-Experience in review and approval of promotional review process strongly preferred

-Comprehensive Knowledge of Design Control processes and controls

-Comprehensive Knowledge of Regulatory Standards needed in the medical device environment.

Please send suitable resumes in confidence to JPCuadra @ openscientific.com