Edwards Lifesciences Sr Spec, Regulatory Affairs in North Ryde, Australia
Completes and maintains regulatory approvals and clearances of assigned products.
Key Responsibilities include but not limited to:
• Prepare and review product registration tasks covering the new product registration, progress reports, supplements, amendment, periodic reports and the renewal registration
• Support and coordinate with other functions to fulfill company’s regulatory tasks mandated by other existing local healthcare regulations, such as the completion of the device registration and tracking monthly reports, the device advertising application, the facilitation of device import exemption and other new regulatory requirement projects assigned by the authority bodies.
• Maintain good relationship with government authorities to keep up to date on regulations changes and trends; seek advice on interpretation of government guidelines and regulations to ensure compliance
• Support and carry out company internal regulatory, quality and compliance processes investigation, recall reporting
• Track timelines and document milestone achievements, develop regulatory strategy, prioritize strategies/submissions with operating plans as well as ensuring alignment with in country/regions strategic plans and provide regulatory updates to relevant stakeholders
• Obtain approvals from relevant authorities on the pricing and reimbursement levels
• Provide guidance and feedback to BUs, including sales and marketing representatives on registration requirements for new and renewal registrations, product and process changes, and review of labeling content and guidance on process improvement projects.
• Review and determine impact of global Change Assessments
• Support and carry out Field Corrective Actions with Regulatory Authorities
• Maintain proper records in systems according to regulatory and quality requirements.
Education and Experience:
Bachelor's Degree or equivalent in related field, 5+ Years years experience Previous related experience.
in Scientific discipline (e.g., medical, pharma, Biology, Microbiology, Chemistry)
Experience in preparing TGA and relevant NZ industry bodies product submissions Preferred
• Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
• Excellent written and verbal communication skills including negotiating and relationship management skills
• Excellent problem-solving, organizational, analytical and critical thinking skills
• Full knowledge and understanding of country/regions regulations relevant to medical devices, Class II and/or Class III devices
• Full knowledge and understanding of country/ regions regulatory requirements for new products or product changes.
• Good leadership skills and ability to influence change
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Work is performed independently on more complex projects and/or lines of work and reviewed for accuracy and soundness
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.