Regulatory Affairs Specialist

Regulatory Affairs Specialist - Medical Devices - EUAnteris Technologies is a global structural heart company dedicated to revolutionizing cardiac care. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team.Our mission is to forge new frontiers in cardiac care by pioneering science-driven and measurable advancements to restore heart valve patients to healthy function. Transcatheter Aortic Valve Replacement (TAVR) technologies were originally designed for older, high-risk patients. Today, younger, more active patients need a better solution that will not just open and close but restore healthy heart function. We seek to restore healthy blood flow patterns by creating the world’s first biomimetic TAVR valve, DurAVR THV. This cutting-edge valve, incorporating our proprietary ADAPT anti-calcification technology, is designed to mimic the natural function of a healthy heart valve.We are seeking an experienced Regulatory Affairs Specialist to lead and execute regulatory strategies to ensure compliance with EU MDR 2017/745 and support CE Mark submissions for Anteris’ Class III structural heart devices. This role is critical in preparing technical documentation, interacting with notified bodies, and providing regulatory guidance throughout the product lifecycle. The ideal candidate is an expert in EU MDR with deep experience in Class III cardiovascular or implantable medical devices, who thrives in a fast-paced, global, and cross-functional environment.At Anteris Technologies, you\u2019ll be part of a team dedicated to enhancing the quality of life for patients with aortic stenosis through groundbreaking medical devices. Join us in our mission to revolutionize structural heart solutions.Key ResponsibilitiesDevelop, lead, and implement EU regulatory strategies and submissions, with a primary focus on EU MDR compliance and CE Marking for Class III implantable devices.Prepare and maintain Technical Documentation (Annex II and III), including Clinical Evaluation Reports, Risk Management Files, labeling, and IFUs.Serve as the primary contact for EU regulatory authorities and notified bodies (e.g., BSI, TÜV SÜD), leading Q&A responses and regulatory audits.Provide regulatory input during design and development phases to ensure compliance with applicable standards (ISO 13485, ISO 14971, MEDDEV, MDCG guidance).Monitor changes in EU regulatory requirements and proactively assess the impact on Anteris products and systems.Partner with R&D, Quality, Clinical, and Marketing to support product lifecycle management, including design changes, PMS, and PMCF activities.Support internal audits, CAPAs, and continuous improvement initiatives related to regulatory compliance.This role may be filled at varying levels, e.g., Sr Specialist or Principal, depending on the candidate's previous experience.Internal RelationshipsRegulatory Affairs Team ollaborate on strategy, submissions, and compliance tracking.R&D / Engineering Provide regulatory input during product development and design changes; ensure design documentation supports regulatory requirements.Clinical Affairs Partner to ensure Clinical Evaluation Reports (CERs), PMCF plans, and clinical data meet EU MDR expectations.Quality Assurance Align on audits, CAPAs, and quality system compliance (especially ISO 13485 and MDR-related QMS).Manufacturing / Operations Ensure labeling, UDI, and production processes align with regulatory requirements.Marketing Support claims substantiation and ensure promotional materials comply with regulatory standards.Executive Leadership Brief senior leaders on regulatory risk, status of submissions, and strategic considerations.External RelationshipsNotified Bodies (e.g., BSI, TÜV SÜD) Serve as primary point of contact for CE submissions, audits, and MDR technical file reviews.Regulatory Consultants / Legal Advisors Engage for specialized guidance on evolving regulations or complex submissions.Regulatory Authorities (e.g., Swissmedic, EMA, Competent Authorities) Interface as needed for regional requirements or reporting obligations.Clinical Investigators / KOLs (if involved in PMCF) Collaborate on post-market clinical follow-up data and input for regulatory submissions.Industry Groups / Standards Bodies May represent Anteris or stay informed through participation in regulatory or industry working groups.Required Qualifications & ExperienceA Bachelor\u2019s degree in Engineering, Life Sciences, or a related technical field is required; a Master\u2019s degree is preferred.Minimum of 7+ years of experience in Regulatory Affairs within the medical device industry, with at least 3 years focused on EU MDR and CE marking of Class III devices.Demonstrated success in authoring and managing EU Technical Documentation for cardiovascular, structural heart, or implantable Class III devices.In-depth knowledge of EU MDR 2017/745, ISO 13485, ISO 14971, MDCG guidelines, and other applicable regulations and standards.Experience in engaging with Notified Bodies and responding to regulatory audits or queries.Strong communication, project management, and cross-functional collaboration skills.Fluency in English is required; French or German is a plus.Preferred AttributesExperience with tissue-based medical devices is strongly desiredKnowledge of regulatory requirements in other jurisdictions (e.g., US FDA, TGA, Health Canada) is a plus.Strategic mindset with the ability to operate at both a tactical and leadership level.Self-starter who is comfortable in a high-growth, entrepreneurial environment.What We OfferOpportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.Collaborative and dynamic work environment with a culture of innovation and excellence.Competitive compensation package, including salary and performance-based bonusCareer development opportunities and a chance to be part of a growing company that values its employees.Seniority levelMid-Senior levelEmployment typeFull-timeJob functionLegalIndustriesMedical Equipment Manufacturing #J-18808-Ljbffr