Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

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.