Senior Regulatory Affairs Specialist

Salary Range: $115,000.00 To $130,000.00 Annually About Us We are a global team of like-minded Med-Tech professionals focused on patient centric solutions in a collaborative environment leading to excellent outcomes. We have developed an advanced and unique heart failure therapy technology in the BrioVAD® Left Ventricular Assist System (LVAS). We are introducing the BrioVAD LVAS to Heart Failure clinicians for use with the large number of indicated and untreated patients who could benefit from chronic mechanical circulatory support. The initiation of our INNOVATE™ Trial in the US is only the beginning. We are building a team to develop advanced technology intended to further improve patient outcomes, increase therapy acceptance, and enabling chronic MCS therapy to be accessible to more patients across the globe. The Role BrioHealth Solutions is seeking a skilled and self-motivated Senior Regulatory Affairs Specialist to support the BrioVAD® Left Ventricular Assist System. This individual will partner with cross-functional teams to support product development activities, US and EU clinical studies and regulatory planning and submission activities. What You’ll Do Prepare, review, and maintain FDA submissions supporting the BrioVAD System and the INNOVATE™ Trial, including IDE submissions, supplements, amendments, and annual reports. Partner with Clinical, R&D, Quality, Medical Affairs, and other cross-functional teams to incorporate regulatory requirements into clinical and product development activities. Provide regulatory guidance on clinical protocols, informed consent materials, investigator communications, labeling, device changes, and other study-related documentation. Assess product, manufacturing, software, labeling, and clinical study changes to determine their regulatory impact and applicable FDA reporting or submission requirements. Support FDA communications and meetings by preparing materials, coordinating cross-functional input, and tracking regulatory questions and commitments. Review technical, clinical, and quality documentation for accuracy, consistency, and submission readiness. Monitor changes to U.S. regulations, FDA guidance, and relevant industry standards; evaluate their impact and communicate applicable requirements to internal stakeholders. Maintain accurate regulatory records, submission files, agency correspondence, approvals, and commitments in accordance with internal procedures. Manage multiple regulatory deliverables and timelines while proactively identifying and escalating risks or potential delays. Support EU MDR regulatory strategy and CE marking activities for the BrioVAD® LVAS, including planning for conformity assessment, Notified Body interactions, and maintenance of EU regulatory deliverables. Contribute to preparation, review, and lifecycle maintenance of EU technical documentation, including General Safety and Performance Requirements (GSPR) evidence, clinical evaluation documentation, post-market surveillance inputs, and related submission-ready records. Support EU clinical and post-market obligations, including clinical investigation documentation, PMCF planning, vigilance inputs, field safety communications, periodic reporting, and responses to regulatory or Notified Body questions, as applicable. Evaluate design, manufacturing, software, labeling, supplier, and clinical study changes for EU regulatory impact, including potential effects on CE marking, technical documentation, GSPR compliance, UDI/EUDAMED data, and Notified Body notification requirements. Coordinate with Authorized Representative, importer/distributor, Notified Body, and internal stakeholders to ensure EU regulatory commitments, timelines, and evidence needs are identified, tracked, and fulfilled. What You Bring Bachelor’s degree in life sciences, engineering, or a related technical discipline required; advanced degree preferred. At least five years of medical device regulatory affairs experience with a bachelor’s degree, or at least three years with an advanced degree. Working knowledge of applicable U.S. medical device regulations, including 21 CFR Parts 11, 50, 54, 56, 812, and 820. Experience preparing or supporting FDA medical device submissions, such as IDE or PMA submissions, supplements, amendments, annual reports, and regulatory responses. Working knowledge of EU MDR 2017/745 requirements, including CE marking, technical documentation, GSPR, clinical evaluation/PMCF, PMS, vigilance, UDI, and EUDAMED expectations. Experience supporting Notified Body submissions or interactions, EU technical documentation, and/or CE mark maintenance for Class III, implantable, active, cardiovascular, or life-sustaining medical devices preferred. Familiarity with ISO 13485, ISO 14971, applicable harmonized standards, MDCG guidance, and EU medical device regulatory intelligence processes preferred. Experience supporting medical device clinical studies and collaborating with clinical, technical, and quality teams. Class III medical device experience strongly preferred; experience with active implantable, cardiovascular, or life-sustaining devices is highly desirable. Ability to assess regulatory requirements and implications across product, software, manufacturing, labeling, and clinical study changes. Strong technical writing, communication, analytical, and organizational skills. Ability to manage competing priorities, exercise sound judgment, and work independently in a fast-paced environment. #J-18808-Ljbffr