Senior Specialist, Regulatory Affairs (Americas & ANZ)

Team: Regulatory Affairs – Americas & ANZ 

Reporting To: Director, Regulatory Affairs – Americas & ANZ 

Direct Reports: No 

Location: Sydney (Hybrid or Remote) 

About ResMed 

At ResMed, we pioneer innovative health technologies that transform millions of lives daily. From connected respiratory care to cloud-based software solutions, our devices span the globe and connect patients, providers, and data to improve healthcare outcomes. We are proud to lead in the medical device space, where quality, compliance, and patient trust are at the heart of our innovation.

Regulatory Affairs (RA) at ResMed is central to ensuring timely and compliant access to global markets. We work across more than 140 countries to deliver safe and effective innovations that improve quality of life. With global reach, deep technical knowledge, and strong regulatory partnerships, we lead with integrity and clarity to shape the future of health technology. 

Team Overview: QARA – Global Regulatory Affairs 

The RA Global team is located at various offices around the world and is responsible for compliance with multiple regulatory frameworks as it relates to design, development and manufacture of products as well as services which meet our customer’s requirements.

• Participate in regional cross functional teams, by providing regulatory strategy, timelines, and deliverables; working closely with product development, clinical, marketing, and commercial functions to assure appropriate requirements are defined for the specific device/channel, including claims and target patient population within each market. 

• Manage the preparation and compilation (i.e., submission document creation, legalization/apostille) for premarket registrations for ANZ and Americas, as well as continuance of regulatory compliance (particularly post market) of existing ResMed products, including software as a medical device. 

• Control and maintain regulatory records, including, but not limited to: submission documentation, tracking of part number approval per country, establishment registrations, import for export, etc. 

• Support initiatives related to regional entity creations (including eCommerce). 

• Ensure timely, professional, and proactive communications with: (1) internal customers to ensure transparency of the regulatory strategic plans, updates/changes, and impact to projected timeframes; (2) external customers to ensure applications are submitted to local health authorities consistent with regulatory strategic plan; and (3) health agencies/consultants to ensure adequate and appropriate information is provided as well as driving submissions to approval as effectively as possible. 

• Monitor and maintain high level of awareness on external standards (technical publications, articles, and abstracts) that will influence our business through internal and external networks. 

• Accurately and timely share and recommended solutions to the global regulatory network on any potentially significant regulation or standard changes that will impact the business. 

• Demonstrate continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including ANZ and Americas country specific regulations, and policies applying to medical devices, global registration, technical writing, etc.