Edwards Lifesciences Veterans Jobs

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Edwards Lifesciences Regulatory Affairs, Associate Specialist in North Ryde, Australia

Assist in managing Regulatory Affairs activities for Australia and New Zealand

Key responsibilities:

  • Assist RA team with developing in-country annual strategy on new product introduction pipeline.

  • Assist RA team with planning of registration activities within agreed timeline in order to deliver regulatory licenses ensuring regulatory compliance and approval for market access

  • Build and maintain relationships with local authorities, in Australia & New Zealand

  • Assist RA team with developing solutions on regulatory issues and present to internal and external stakeholders

  • Assist RA team with the review and approval of Marketing Material ensuring the database is always current

  • Prepare documents in electronic file for regulatory submission dossiers

  • Support FCA’s where required Maintain the Australian Technical files for approved products

  • Other ad hoc duties

Education and Experience:

  • Bachelor's Degree in related field, preferably with 12 months of experience

  • Experience working in a healthcare company required

  • Certification in related discipline preferred e.g. ISO13485 auditor certification

Additional skills:

  • Good knowledge and understanding of local regulations relevant to Medical Devices; class I, II and/or Class III

  • Proven successful project management skills

  • Proven expertise in both Microsoft Office Suite and government regulatory systems

  • Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives

  • Good presentation skills

  • Good written and verbal communication skills in English and interpersonal relationship skills in reading, writing and speaking English

  • Ability to build stable working relationships internally

  • Knowledge of regulatory affairs within the organisation

  • Knowledge of Edwards products

  • Knowledge of healthcare industry

  • Strict attention to detail

  • Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization

  • Ability to manage competing priorities in a fast paced environment

  • Develop solutions to a variety of problems of basic scope and complexity

  • May participate in process improvements

  • 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.