Job Description

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. Ensuring 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 customers quality requirements. Working closely with all internal stakeholders and external regulators to achieve business goals.Lets talk about Responsibilities

• Support and maintain various internal/ government databases relevant to Resmed's operations.
• Define and communicate requirements for internal systems to ensure alignment with government database requirements.
• Conduct regular internal reviews of data to ensure accuracy, completeness, and compliance.
• Collaborate with cross-functional teams to ensure regulatory requirements are integrated into product development and business processes.
• Stay up-to-date with changes in regulatory environment and best practices.
• Builds productive internal/external working relationships.
• Occasionally leads the work of project teams and might formally train junior staff.

Lets talk about Qualifications and ExperienceRequired:

• Bachelors degree in a related field such as life sciences, legal studies, or healthcare administration.
• 5-7 years of experience in regulatory affairs, preferably within the healthcare or medical device industry.
• Strong understanding of enterprise systems, government databases and regulatory requirements.
• Excellent analytical and organizational skills, with the ability to manage multiple projects simultaneously.
• Proficient in Microsoft Office Suite and database management.
• Strong communication skills, both written and verbal, with the ability to effectively interact with all levels of management and government agencies.

Technical Skills:

• Proficiency in Regulatory Information Management Systems (RIMS).
• Experience with data warehousing platforms such as Snowflake.
• Familiarity with Oracle database systems.
• Knowledge of document management systems like Objective.

Preferred:

• Experience with international regulatory affairs.
• Familiarity with Resmed products and the respiratory care industry.

Joining us is more than saying yes to making the world a healthier place. Its discovering a career thats 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!Joining us is more than saying yes to making the world a healthier place. Its discovering a career thats 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!

ResMed