Senior Specialist, Regulatory Affairs (Americas & ANZ)

Job description

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 wit h multiple regulatory frameworks as it relates to design, development and manufacture of products as well as services which meet our customer’s requirements. Based in Australia, you will manage and execute the planning, development and implementation of RA strategies for new and existing business channels in ANZ and the Americas (Australia, New Zealand, North and South America). You will also provide regional regulatory support to operational activities for ANZ including label review and submissions. You will be part of and collaborate closely with other global and regional RA teams. Position Summary 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, many of which may not be medical devices products in all markets, 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. You’ll also serve as a mentor to peers, ensuring technical consistency, clarity, and excellence in regulatory execution. Let’s talk about Responsibilities 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. Let’s talk about Qualifications and Experience Bachelor’s degree in a Life Sciences , Engineering , or related discipline. Equivalent experience will also be considered. 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 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 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! We commit to respond to every applicant.