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About the Role
As a Regulatory Affairs Specialist – Americas & ANZ, you will develop and execute innovative regulatory strategies for products and services. You will lead regulatory change assessments in your region. This role requires the ability to look over a broad portfolio of products, understanding the nuance of such differences and providing the business with actionable strategies to support growth. You will collaborate across Regulatory Affairs, Quality, Product Marketing, Revenue and Supply Chain, and serve as a mentor to peers, ensuring technical consistency, clarity, and excellence in regulatory execution.
Responsibilities
- Participate in regional cross-functional teams, providing regulatory strategy, timelines, and deliverables.
- Manage the preparation and compilation for premarket registrations for ANZ and Americas, and continuance of regulatory compliance for existing products.
- Control and maintain regulatory records, including submission documentation and establishment registrations.
- Support initiatives related to regional entity creations.
- Ensure timely, professional, and proactive communications with internal customers, external customers, and health agencies/consultants.
- Monitor and maintain high level of awareness on external standards that will influence the business.
- Share and recommend solutions to the global regulatory network on any significant regulation or standard changes.
- Demonstrate continuous pursuit of regulatory knowledge in product submissions and regulatory topics for ANZ and Americas.
Requirements
- Bachelor’s degree in a Life Sciences, Engineering, or related discipline, or equivalent experience.
- 6 to 8 years’ regulatory experience in handling regulatory work for medical devices or pharmaceuticals specifically in the ANZ region.
- Experience with other regulated markets is a plus.
- Desirable experience with entity licensing for import/distribution of health products.
- Strong interpersonal communication skills in English.
- Knowledge of ISO 13485, ISO 14971, design control requirements, post-market surveillance, and risk management principles.
- Experience with software-based medical devices, digital health technologies, or connected healthcare products.
- Regulatory Affairs Certification (RAC) or progress toward RAC certification preferred.
- Experience working in matrixed global organizations and influencing stakeholders without direct authority.
- Creative, detail-oriented, resourceful, highly organized, and able to prioritize workload and work independently.
Skills
- Regulatory strategy
- Regulatory change assessments
- Product submissions
- Technical writing
- Interpersonal communication
- ISO 13485
- ISO 14971
- Design control
- Post-market surveillance
- Risk management
- Software-based medical devices
- Digital health technologies
- Connected healthcare products
Location
- Sydney
Work Type
- Hybrid
- Remote
Experience Level
- 6 to 8 years
Education Level
- Bachelor’s degree in a Life Sciences, Engineering, or related discipline
About the Company
- ResMed pioneers innovative health technologies that transform millions of lives daily, from connected respiratory care to cloud-based software solutions.
- ResMed's devices span the globe and connect patients, providers, and data to improve healthcare outcomes.
- ResMed leads in the medical device space, where quality, compliance, and patient trust are at the heart of innovation.
- The RA Global team is responsible for compliance with multiple regulatory frameworks as it relates to design, development and manufacture of products as well as services which meet customer requirements.
- ResMed focuses on creating a diverse and inclusive culture, encouraging individual expression and innovative ideas.