Regulatory Affairs Manager

Headquartered in the U.S., our client is a division of a global company devoted to the research and development, manufacturing, and distribution of highly specialized products for Healthcare and Life Sciences worldwide. This is a great step for someone who has progressed to a Manager level and wants to progress into a Director role in the future. If you are looking to take on a challenging role within a rapidly growing division that provides an A+ environment and excellent benefits, do not miss out on a potential opportunity to get your foot in the door. 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 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 Additional Information All your information will be kept confidential according to EEO guidelines. #J-18808-Ljbffr