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Clinical Development Specialist – Diagnostics

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ResMed

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Location:
Malaysia; Singapore , Kuala Lumpur ▼

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

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Job Description:

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.

Job Responsibility:

  • 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

Requirements:

  • 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

Nice to have:

  • 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

Additional Information:

Job Posted:
February 20, 2026

Employment Type:
Fulltime
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