The primary role of the Regulatory Affairs (RA) function is to provide support and guidance with respect to regulatory environment, at all stages of the life cycle of ResMed's products. The Regulatory Affairs Department is required to ensure that management systems are established to enable ResMed to comply with, and be able to readily display their compliance with, multiple regulatory frameworks and to support the design, development and manufacture of products which meet regulatory requirements. The RA Systems and Business Excellence team ensures that tools, systems and processes are established to enable RA function to perform its role efficiently and with 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 polices, regulations and guidance documents issued by global regulatory agencies

Coordinate

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 who 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 thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!