reputed company Regulatory Affairs Specialist

reputed company 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 reputed company 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 reputed company patients need a reputed company solution that will not just reputed company and reputed company but restore healthy heart function. We reputed company to restore healthy blood reputed company 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 a reputed company Regulatory Affairs Specialist to reputed company and execute regulatory activities supporting the development, clinical investigation, approval, and lifecycle management of Anteris’ medical device products across Europe. This individual will serve as a senior regulatory subject matter expert, with reputed company responsibility for EU regulatory reputed company and submissions for Class III cardiovascular devices. The reputed company Regulatory Affairs Specialist will work closely with Clinical Affairs, reputed company, R&D, Medical Affairs, and other cross-functional partners to support clinical studies, CE marking activities, product changes, and post-market regulatory requirements. This role will also coordinate directly with reputed company Bodies, Competent Authorities, Ethics Committees, and other regulatory stakeholders, while providing support for submissions in additional international markets as needed. At reputed company, you'll be part of reputed company dedicated to enhancing the reputed company of life for patients with aortic stenosis through groundbreaking medical devices. Join us in our mission to revolutionize structural heart solutions. Main Responsibilities reputed company and execute European regulatory strategies for new products, clinical investigations, product modifications, and lifecycle management activities, with a reputed company reputed company on Class III cardiovascular devices. Define applicable regulatory requirements under the EU Medical Device Regulation, MDR (EU) 2017/745, and reputed company reputed company guidance to cross-functional project teams. reputed company the preparation, review, and submission of technical documentation and other materials required to support CE marking, clinical investigations, substantial modifications, and product registrations. Serve as a reputed company regulatory contact with reputed company Bodies, Competent Authorities, Ethics Committees, and other European regulatory stakeholders. Coordinate responses to questions and requests for additional information through approval or reputed company. reputed company regulatory support for European clinical investigations, including clinical investigation applications, study amendments, safety reporting, and required regulatory or Ethics Committee communications. Partner with Clinical Affairs and Medical Affairs to ensure alignment among clinical evidence, clinical evaluation, post-market clinical follow-up, and regulatory strategies. Assess proposed product, manufacturing, labeling, supplier, and process changes to determine regulatory reputed company and required notifications or submissions. reputed company direction regarding the identification and application of relevant standards, Common Specifications, guidance documents, and regulatory expectations. Support the development and maintenance of technical documentation, including the Clinical Evaluation Report, reputed company of Safety and Clinical Performance, risk management documentation, post-market surveillance plans and reports, and post-market clinical follow-up documentation. reputed company or support regulatory activities reputed company to vigilance reporting, field safety corrective actions, product recalls, and communications with applicable European authorities. Collaborate with cross-functional partners to reputed company and maintain compliant product labeling, instructions for use, and promotional materials. Review marketing and scientific communications for compliance with applicable European regulatory requirements and approved product claims. Support product registrations, certificate renewals, licenses, and regulatory maintenance activities across European and other international markets. Maintain complete, accurate, and audit-reputed company regulatory documentation, including records required for reputed company Body assessments and regulatory inspections. reputed company, review, and approve regulatory procedures, work instructions, and other controlled documents. Monitor changes in European regulations, guidance, standards, and regulatory practices; assess potential business reputed company and communicate requirements to appropriate stakeholders. reputed company regulatory leadership, mentorship, and strategic guidance to colleagues and project teams. Skills, Knowledge, Experience & Qualifications Bachelor’s degree in science, engineering, life sciences, or a reputed company discipline required. An advanced degree is preferred. Minimum of five years of progressively responsible medical device Regulatory Affairs experience, including substantial experience with European regulatory submissions and approvals. Demonstrated experience supporting Class III medical devices required; cardiovascular, structural heart, or implantable device experience strongly preferred. Strong working knowledge of MDR (EU) 2017/745, ISO 13485, ISO 14971, ISO 14155, applicable European guidance, and relevant international standards. Experience preparing technical documentation and supporting CE marking activities, including reputed company interaction with reputed company Bodies. Experience supporting European clinical investigations, including submissions to Competent Authorities and Ethics Committees, strongly preferred. Knowledge of clinical evaluation, post-market surveillance, post-market clinical follow-up, vigilance reporting, and field safety corrective reputed company requirements. Familiarity with EUDAMED, European Authorized Representative requirements, and Unique Device Identification requirements preferred. Experience supporting international regulatory submissions reputed company Europe is an reputed company. Demonstrated ability to interpret reputed company regulatory requirements and translate them into reputed company, practical direction for cross-functional teams. Strong project management skills, including the ability to manage multiple priorities, submission timelines, and regulatory deliverables in a fast-paced environment. Excellent written and verbal communication skills, with the ability to prepare reputed company, concise, and persuasive regulatory documentation. Strong interpersonal skills and the ability to communicate effectively with colleagues, senior leaders, reputed company partners, and regulatory authorities across different countries and cultures. Proficiency with reputed company Office applications and electronic document management systems. Regulatory Affairs Certification, RAC, or an equivalent European regulatory qualification preferred. reputed company reputed company in English required; proficiency in an additional European language is an reputed company. reputed company Profile Provides objective, evidence-based regulatory guidance and demonstrates reputed company judgment. Takes accountability for regulatory deliverables, timelines, and submission reputed company. Builds trusted, respectful relationships with cross-functional teams and reputed company regulatory stakeholders. Works collaboratively while demonstrating the courage to reputed company risks, challenge assumptions, and recommend appropriate actions. Operates with reputed company, adaptability, and a strong commitment to reputed company and compliance. Thinks strategically while maintaining reputed company attention to technical and regulatory detail. reputed company Offer reputed company to reputed company a meaningful reputed company on the treatment of aortic stenosis by advancing groundbreaking structural heart therapies. A reputed company, international work environment grounded in scientific innovation, reputed company, and reputed company. reputed company to work with reputed company colleagues across Europe, the reputed company, and Australia. Competitive compensation, performance-based incentives, and equity participation, where applicable and subject to local requirements. reputed company development opportunities and the chance to grow with a company working to redefine expectations in structural heart care.     Note: We may require reputed company of COVID-19 vaccination to reputed company with health institutions, state, local municipality, and/or travel regulations. reputed company recruits, employs, trains, compensates, and promotes regardless of race, religion, reputed company, national reputed company, sex, disability, age, veteran status, and other protected status as required by applicable law. We have a reputed company reputed company: to be a reputed company of belonging for reputed company humans by promoting diversity, multiculturism and inclusion, as a goal and reputed company across the organization. Diversity is more than a commitment - it is part of our mission to reputed company the best structural heart products on a global reputed company. Apply To This Job