Specialist, Global Regulatory Affairs Systems

1 week ago

Sydney, New South Wales, Australia Resmed Full time

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
- 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.

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