Senior Clinical Research Specialist

Huawei; Helsinki; On-site; EUR 60 000 - 80 000; Full time

Job summary

A leading technology firm is seeking a Senior Clinical Research Specialist to guide clinical investigations and ensure compliance with EU regulations. This role involves collaboration with CROs and managing clinical strategies using innovative wearable technologies. Ideal candidates will have a Master’s degree and extensive experience in clinical trials, particularly with medical devices.

Benefits

Growth opportunities

Innovative work environment

Dynamic team culture

Contribution to health technology

Qualifications

• Master’s degree or above in Biomedical Engineering, Clinical Research or relevant discipline.
• Minimum 5 years of experience in clinical trials or affairs.
• Proven experience working with CROs on clinical studies.
• Strong documentation management skills.

Responsibilities

• Lead the clinical strategy for EU MDR compliance.
• Collaborate with CROs for clinical investigations.
• Ensure clinical documentation meets regulatory requirements.
• Coordinate with internal teams for alignment.

Skills

Communication skills

Project management

Regulatory knowledge

Documentation quality

Education

Master’s degree in Biomedical Engineering or Clinical Research

Tools

Clinical audit preparation

Technical document management

Job description

Overview

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/Switzerland.

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!

Benefits

• 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: https://www.youtube.com/watch?v=xBNBCI8K4Jc

About Huawei

Huawei is a leading global provider of information and communications technology (ICT) infrastructure and smart devices. With integrated solutions across four key domains – telecom networks, IT, smart devices, and cloud services – we are committed to bringing digital to every person, home and organization for a fully connected, intelligent world.

At Huawei, innovation focuses on customer needs. We invest heavily in basic research, concentrating on technological breakthroughs that drive the world forward. We have 207,000 employees, and we operate in more than 170 countries and regions. Founded in 1987, Huawei is a private company fully owned by its employees.

Huawei continues to invest in basic research and open innovation, and accommodates and addresses customer needs with an open mind, while steering these needs with science and technology. We have also built flexible business models and encourage numerous industries to adopt a vast range of models and applications. Through such initiatives, we are bringing digital to every person, home and organization for a fully connected, intelligent world.

We seek and reward talent! At Huawei, if you are dedicated to creativity, engagement of technical risks and delivery of target-driven results, your efforts will be rewarded with outstanding career prospects.

About Huawei Finland R&D

With 28 sites across Europe and over 2000 researchers, Huawei’s European Research Institute (ERI) oversees fundamental and applied technology research, academic research cooperation projects, and strategic technical planning across our network of European R&D facilities. Huawei Finland Research Center was established in 2012. At our sites in Helsinki and Tampere, you will have an outstanding opportunity to be part of the leading research and development of future smart devices. We offer a career in a forward-looking industrial research team with a solid track record in innovation and publication and delivering its result as factual contributions to on-the-market devices.

Benefits

Huawei offers opportunity to learn from the best of mobile industry. Working at Huawei in international atmosphere is fun and the opportunity to develop your skills and competences is endless. Are you ready for the challenge?