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The Operations team partners closely with ResMed’s five business leaders to understand their needs then providing a variety of products and services to help them meet those needs including Customer and Technical Services, Global Quality Assurance and Regulatory Affairs, Supply Chain, manufacturing, logistics and distribution. Focused on enabling new product introduction and operating excellence, our team strives to improve time to market for new products and services, improve efficiencies in our cross-functional processes, and improve our supply chain through digitization and automation to increase value add to our customers.

Let’s Talk About The Team And You

The primary role of the Regulatory Affairs function is to provide support and guidance with respect to regulatory environment, at all stages of the life cycle of ResMed's products. Key deliverables include adding value to business through ensuring compliance and delivery of optimal regulatory strategies for portfolio planning, active regulatory intelligence and excellence in execution. The team ensures that systems and processes are established to enable ResMed to comply with multiple regulatory frameworks, in order to support the design, development and manufacture of products which meet our customer’s quality requirements. You will be working closely with all internal stakeholders and external regulators to achieve business goals.

Let’s Talk About Responsibilities

• To provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safe and effective devices to patients globally.
• Strategic regulatory planning, keeping abreast of regulatory changes and assessing business impact
• Support product submission/registration/renewals, labelling and advertising review as well as post market compliance activities including regulatory assessment of product changes
• Support regulatory audits, and recalls, interaction and communication with internal business units and regulatory agencies.
• Contribute to and manage assigned projects, leveraging on professional expertise and relationships to drive business result
  
  

Let’s Talk About Qualifications And Experience

• Bachelor’s degree in a relevant discipline (e.g. Engineering, Sciences, Lifesciences)
• Preferably 2 years of related experience in regulatory and/or quality department, within a medtech/healthcare manufacturing environment.
• Strong communication, analytical and problem solving skills
  
  

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!