Clinical Development Specialist – Diagnostics

The Medical Affairs team collaborates with the leaders of Sleep, Respiratory Care, SaaS, ResMed Healthcare, and Asia Growth Markets to ensure our work, especially our clinical research and market access projects, align with their strategic priorities. We also review key government policies, as part of the continuous evaluation and improvement process that helps us maintain global compliance across an ever-shifting landscape of legal and regulatory requirements. The two, research and compliance, work hand-in-hand, and when balanced properly allow us to generate important clinical, economic and market evidence, that improves the lives of patients in ways that are scientifically valid, clinically relevant and ethically sound.

Let's talk about the team:

The primary role of Clinical Science & Innovation function is to develop new product concepts, prototypes and technologies, that are aligned to ResMed's strategy. Key deliverables include developing business cases with strategic focus and commercial value that enables a global view of clinical science and deep technology as it pertains to ResMed's world.

Let's talk about the role:

We are seeking an enthusiastic and detail-oriented Clinical Development Specialist – Diagnostics to join our Medical Affairs team. In this role, you will play a critical part in the design, implementation, and oversight of clinical development activities that support our sleep diagnostics portfolio. You'll work cross-functionally to ensure that our products have the correct requirements and to define and execute on strategies to generate high-quality evidence to support the safe and effective use of diagnostic solutions across various healthcare settings.

This is a unique opportunity to contribute to the development of cutting-edge diagnostics that enable timely, accurate decision-making for patients and providers.

Key Responsibilities:

• Support the planning and execution of clinical studies—including analytical validation, clinical validation, and usability studies—aligned with diagnostic development goals.

• Assist in developing study protocols, investigator brochures, case report forms (CRFs), and other clinical study documents.

• Collaborate with internal stakeholders such as Regulatory Affairs, Clinical Operations, R&D, and Marketing to ensure integrated study planning and execution.

• Liaise with external investigators, clinical sites, and contract research organizations (CROs) to support effective study conduct and data integrity.

• Participate in data analysis and interpretation activities to support product development, regulatory submissions, and scientific communications.

• Track study timelines, milestones, and budgets to ensure clinical projects are completed on time and within scope.

• Maintain a strong understanding of diagnostic regulatory pathways (e.g., FDA, CE-IVD, CLIA) and ensure compliance with applicable clinical and ethical guidelines.

• Contribute to the development of abstracts, posters, and manuscripts to communicate clinical evidence to external audiences.

Let's talk about you:

Required:

• Bachelor's degree in life sciences, biomedical engineering, public health, or a related field.

• 3+ years of experience in clinical development or clinical research, with a focus on diagnostics, in vitro diagnostics (IVDs), or medical devices.

• Familiarity with clinical validation and usability studies for diagnostics.

• Working knowledge of Good Clinical Practice (GCP), ISO 14155, and diagnostic regulatory frameworks.

• Strong organizational skills and the ability to manage multiple projects simultaneously.

• Excellent verbal and written communication skills.

• Highly skilled in stakeholder management across different regions and time-zones.

Preferred:

• Advanced degree (e.g., MS, PhD, MPH)

• Experience supporting regulatory submissions for diagnostic products (e.g., 510(k), PMA, IVDR)

• Prior work in a Medical Affairs or translational science environment

• Experience with diagnostic studies in sleep disorders and respiratory care

Core Competencies

• Scientific and Technical Expertise

• Project Management

• Diagnostic Regulatory Knowledge

• Cross-functional Collaboration

• Strategic Thinking

• Communication and Presentation

• Quality and Compliance Focus

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.