Specialist,Regulatory Affairs Digitization
2 weeks ago
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 customer’s quality requirements. Working closely with all internal stakeholders and external regulators to achieve business goals.
Let’s talk about Responsibilities
Let’s talk about Qualifications and Experience
Required:
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. 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
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
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