Regulatory Affairs Specialist

TitleRegulatory Affairs SpecialistReports toVP of Quality & Regulatory AffairsLocation: Remote initially then transitions to on-site (Irvine, CA office)Salary Range: $110,000 - $120,000 per yearLocal candidates only; no relocation will be provided for this position.The Kardion Regulatory Affairs team is seeking a high energy, driven individual who is looking for the unique opportunity and challenge provided by a clinical stage startup. You will join a small team who left great jobs to go "all in" with Kardion to bring a great product that they passionately believe in to market. Communication skills, humility, competitive spirit and team fit are paramount. The Regulatory Affairs Specialist is a key partner within Regulatory Affairs and will have responsibility of the direct execution of some corporate regulatory filings. This role will work independently on some submissions and partner with others in the Regulatory Team on other US FDA filings, including IDEs, 510(k)s and PMA. This position requires someone with both a strong execution mindset and ability to explain regulatory processes to the organization.Position will initially be remote then transition to on-site when the Irvine, CA office location is available, mid-2025.Essential ResponsibilitiesDrive and author parts or whole regulatory submissions, including FDA IDEs, Q-Subs, 510(k)s and PMAsProvide input and technical guidance on regulatory requirements to product development and operations teamsSupport new product launch, risk management activities, regulatory plans, product V&V, process validations, and design transfer into manufacturingStrategize and develop regulatory plans and documents for new products, product updates, manufacturing process changes, marketing materials, and clinical trialsReview and interpret regulatory rules as they relate to company products and procedures, clinical studies, testing or records keeping and ensure that they are communicated through company policies and proceduresMaintain present awareness of FDA and global regulations, guidance, and standards applicable to company productsExercise good and ethical judgment within policy and regulationsPerform multiple tasks concurrently with accuracyProvide guidance to functional groups in the development of relevant data to complete a regulatory submissionOther duties as assigned.Skills, Qualifications & Key Knowledge AreasBachelor's degree in engineering, science or related field or equivalent experience is requiredMinimum of 5 year's regulatory experience in a medical device firm is requiredExperience drafting FDA 510(k)s and parts of PMA submissions is requiredExperience with complex medical devices, incorporating electro mechanical and disposable components highly desiredExperience with interventional cardiology devices highly desiredAbility to exercise sound judgment and decision making Exceptional communication skills across functional areas and roles within organization Experience with remote team engagement requiredAbility to travel both internationally and domestically, up to 20% at peak times

Created: 2025-03-06