Senior Clinical Research Specialist
Huawei Finland R&DAbout the role
Position Summary
We are looking for a Senior Clinical Research Specialist to join our Huawei Helsinki Research Center. In this role, you will act as a key liaison between internal teams and Contract Research Organizations (CROs), ensuring clinical investigations are designed, executed, and documented in full compliance with EU MDR, ISO 14155, and related standards. A key focus will also include identifying and managing IHI and other EU-funded projects, leveraging Huawei’s wearable technologies and health algorithms to advance clinical research in cardiology, sleep science, endocrinology, and sports health.
Key Responsibilities:
- Lead and manage the full clinical strategy and execution for EU MDR compliance of digital health products (e.g., wearables, health monitoring algorithms), ensuring alignment with scientific, regulatory, and GCP standards.
- Collaborate with CROs and clinical partners to design, initiate, and oversee clinical investigations, including protocols, site selection, ethics submissions, monitoring, data collection, and study close-out.
- Ensure all clinical documentation—protocols, IBs, ICFs, reports—meets MDR, ISO 14155, and Notified Body requirements.
- Coordinate with internal teams (e.g., R&D, legal, regulatory) to align clinical evidence with safety and performance claims.
- Track and respond to changes in the EU regulatory landscape, proactively adjusting plans and documentation.
- Lead academic collaborations by identifying and engaging KOLs, hospitals, and research institutions in cardiovascular, metabolic, and related health domains.
Requirements:
- Master’s degree or above in Biomedical Engineering, Clinical Research, Regulatory Affairs, or a relevant medical/life science discipline.
- Minimum 5 years of experience in clinical trials or clinical affairs, preferably with Class II or Class III medical devices.
- Proven experience working with or managing CROs on clinical studies for MDR certification.
- In-depth knowledge of EU MDR (2017/745), ISO 14155, and other relevant regulatory and ethical guidelines.
- Strong documentation and quality mindset—able to manage high volumes of technical and regulatory documents accurately.
- Excellent communication and coordination skills in English (spoken and written).
- Experience working with Notified Bodies, and preparing for clinical audits or regulatory inspections is a strong advantage.
Preferred Skills:
- Knowledge or experience of digital biomarkers, physiological signal processing, wearables or AI-assisted clinical assessments.
- Involvement in standardization bodies or academic committees is a plus.
- Multinational project management experience across EU-based clinical sites.
Contract period and starting date: The position is a full-time/long term contractor position. and the contract will be signed with our supplier. We expect the role to start as soon as possible.
Working place: Finland (onsite at Helsinki) or UK/Germany/Switzerlandf.
Why Join Us?
Join the #1 ranked company in the world for on-the-wrist wearables! At Huawei, we're redefining the future of sports and health technology. With a market share of 16.9% in the first 3 quarters of 2024, we're leading the charge in the wearable industry.
Our ground-breaking technology, including HUAWEI WATCH FIT 3, HUAWEI WATCH GT 5 and the award-winning WATCH D2 – ambulatory blood pressure monitoring watch has been recognized as top class sports and health monitoring devices. As part of our team, you'll have the opportunity to work with the most experienced experts in the field and make a real impact on the future of consumer wearables.
If you're driven by innovation and passionate about making a difference, we want you to join us in shaping the future of sports and health technology. Apply now to take your career to the next level!
- Innovative Work: You’ll be working at the cutting edge of wearable product technology, with opportunities to tackle complex and meaningful challenges.
- Impact: Your work will directly contribute to the development of products that improve human health, performance, and safety.
- Growth Opportunities: We foster a culture of continuous learning, providing opportunities for professional development and career advancement.
- Exciting Work Environment: Join our dynamic sports science lab, and be part of the cool team! Check out our lab here:
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