Specialist, Global Regulatory Affairs Systems - BusX (12 Month Contract) Locations: Sydney, NSW, Australia
Time Type: Full time
Posted on: Posted Yesterday
Job Requisition ID: JR_035420
The primary role of the Regulatory Affairs (RA) function is to provide support and guidance with respect to the regulatory environment at all stages of the life cycle of ResMed's products. The Regulatory Affairs Department ensures that management systems are established to enable ResMed to comply with and readily display their compliance with multiple regulatory frameworks, supporting the design, development, and manufacture of products that meet regulatory requirements. The RA Systems and Business Excellence team ensures that tools, systems, and processes are established to enable the RA function to perform its role efficiently and at scale. You will be working closely with all internal stakeholders and external regulators to achieve business goals.
Let's talk about the role: We are offering a 12-month fixed term contract. You will be part of the Regulatory Affairs - Systems and Business Excellence Team located in Sydney (Bella Vista and/or remote hybrid working arrangement) and perform regulatory activities as directed, including:
Manage the continuance of regulatory compliance of existing ResMed products Review new and changing policies, regulations, and guidance documents issued by global regulatory agencies Maintenance and analysis of corporate and regulatory specific data Initiate, support, and coordinate process improvement projects related to operational processes, digital tools, and databases Assist with regulatory submissions, regulatory license applications, and technical documentation audits Represent Regulatory Affairs on cross-functional business projects Support the Regulatory Affairs team in project tasks as they arise Work within the ResMed Quality system Position Specific Skills and Challenges Excellent attention to detail, strong organizational and communication skills Ability to work within a team and also independently Ability to prioritize, coordinate multiple projects simultaneously, and work to timelines Agility and flexibility Strong understanding of global regulatory requirements and submission processes Let's talk about Qualifications and Experience Bachelor's degree in Engineering, Computer Science, Life Sciences, Regulatory Affairs, or a related field Minimum of 3-5 years of experience in regulatory affairs within the medical device industry Familiarity with ISO 13485, ISO 14971, FDA 21 CFR Part 820, and other relevant standards and regulations We are looking for someone who is a quick learner, adaptable, and enjoys working with a team.
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 thriving on the innovative ideas this generates. If this sounds like the workplace for you, apply now!
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