Operations Project Manager （IVD/FemTech）

Shanya International Limited; Hong Kong; On-site; HKD 600,000 - 900,000; Full time

Job summary

Shanya International Limited in Hong Kong seeks a seasoned Project Manager to lead cross-functional initiatives across R&D, product, clinical, and operations in the medical device space.

You will drive schedules, align with funding requirements, coordinate with manufacturers, laboratories, hospitals, and CROs, and prepare governance materials. Fluency in English and Cantonese/Mandarin preferred.

Qualifications

• 3+ years experience in project management / operations within IVD, MedTech, biotech, diagnostics, healthcare, or regulated product industries.
• Strong understanding of execution processes in product development environments.
• Experience working with manufacturers, laboratories, hospitals, or external vendors.
• Excellent organizational skills with strong attention to detail and multilingual communication.

Responsibilities

• Manage cross-functional timelines, deliverables, and milestones across R&D, product, clinical, and operations.
• Ensure projects remain on schedule, within scope, and aligned with funding requirements.
• Build and maintain project trackers, weekly updates, and execution dashboards.
• Drive accountability across internal and external stakeholders.

Skills

Project management

Operations

Cross-functional collaboration

English & Chinese communication

Education

Bachelor’s degree or above in Life Sciences/Biomedical Engineering/Healthcare Management/Business

Job description

Key Responsibilities1. Project Management & Execution

• Manage cross-functional timelines, deliverables, and milestones across R&D, product, clinical, and operations
• Ensure projects remain on schedule, within scope, and aligned with funding requirements
• Build and maintain project trackers, weekly updates, and execution dashboards
• Drive accountability across internal and external stakeholders2.Prototype & Manufacturing Coordination
• Coordinate with external product developers, OEM / ODM manufacturers, and suppliers
• Support prototype development, testing schedules, packaging, and pilot production
• Manage vendor communication, quotations, contracts, and delivery timelines
• Clinical & Research Program Support
• Assist in planning and execution of pilot studies / clinical validation programs
• Coordinate with hospitals, clinicians, CROs, laboratories, and research collaborators
• Support ethics submission preparation, study documentation, participant logistics, and data collection workflows
• Track clinical milestones and documentation readiness
• Funding & Administrative Operations
• Support reporting requirements for government grants / incubation programs
• Prepare progress reports, milestone summaries, meeting materials, and operational documentation
• Maintain organized records for audits, IP submissions, vendors, and project files
• Strategic Growth Support
• Assist Founder in partnership discussions, exhibitions, investor preparation, and business development follow-up
• Help identify opportunities in FemTech / diagnostics / digital health ecosystems

Requirements Must Have

• Bachelor’s degree or above in Life Sciences, Biomedical Engineering, Healthcare Management, Business, or related disciplines
• 3+ years experience in project management / operations within IVD, MedTech, biotech, diagnostics, healthcare, or regulated product industries
• Strong understanding of execution processes in product development environments
• Experience working with manufacturers, laboratories, hospitals, or external vendors
• Excellent organizational skills with strong attention to detail
• Strong communication skills in English and Chinese (Cantonese / Mandarin preferred)

Highly Preferred

• Experience in IVD product development or clinical validation programs
• Familiarity with regulatory pathways (NMPA / CE / FDA) is a plus
• Experience with government-funded innovation programs or startup environments
• Interest in women’s health / FemTech / digital health innovation
• Experience managing multiple parallel projects independently