Regulatory Technical Documentation Specialist – Medical Devices (CER)
Regulatory Technical Documentation Specialist – Medical Devices (CER)
We are seeking an experienced Medical Device Documentation Specialist for an exciting international project with a leading company
in the healthcare industry.
In this role, you will play a key part in the development of Clinical Evaluation Reports (CERs) for a major NMPA submission
targeting the Chinese market. You will work closely with leading experts in ultrasound technology, clinical affairs, and
regulatory affairs in a highly specialized international environment.
Key Responsibilities
This is a hands-on, technically focused role for a professional with experience in Clinical Evaluation Reports (CERs) and
regulatory documentation for medical devices.
You will be responsible for developing and quality-assuring a complete CER package for an advanced ultrasound platform consisting
of approximately 20 probes and 25 software applications/features.
Qualifications
Bachelor's degree or higher in Life Sciences, Biomedical Sciences, Medical Technology, or a related field
Experience writing or reviewing Clinical Evaluation Reports (CERs) for medical devices
Strong understanding of regulatory frameworks such as EU MDR, MEDDEV, FDA, and/or NMPA
Experience with clinical documentation, literature reviews, and evidence generation
Key Responsibilities
Prepare and quality assure Main CERs and associated Sub-CERs
Develop predicate/equivalence assessments and document safety and performance
Ensure traceability between CERs, test data, clinical documentation, and Instructions for Use (IFU)
Conduct complaint and post-market surveillance (PMS) searches
Identify and resolve inconsistencies across regulatory documentation
Collaborate closely with engineers, clinical experts, and international teams in Norway and China
Ensure documentation is delivered within defined regulatory timelines
Demonstrate excellent written and verbal English communication skills
Maintain strong proficiency in Microsoft Word, Excel, and PowerPoint
Preferred Qualifications
Experience with NMPA/CMDE submissions
Experience from larger MedTech organizations
Knowledge of echocardiography and/or diagnostic ultrasound systems
RAC certification or equivalent regulatory qualification
Experience using AI tools to support efficient production of regulatory documentation
Why Apply?
Join a global market leader in medical imaging technology
Contribute to one of the largest NMPA projects GE HealthCare has undertaken in recent years
Work in a highly specialized international environment
Enjoy a high degree of autonomy and professional influence
Flexible work arrangement with remote working possibilities
Excellent compensation package
Desired start date: ASAP
Duration: 3–4 months
For a confidential discussion regarding the role and project, please get in touch. We review applications on an ongoing basis and
are looking for someone who can start at short notice.
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About Akkodis
Akkodis is one of the world's leading companies within Smart Industry.
Akkodis Norway is one of Norway's largest providers of technical consulting services and a preferred supplier of engineering, IT,
and project administration professionals at all levels.
We offer career opportunities both in Norway and internationally, competitive terms and conditions, and professional support
throughout the recruitment process.
Our projects span Renewable Energy, including battery technology, offshore wind, and hydrogen, as well as industries such as Oil &
Gas, Life Sciences & Healthcare, Banking & Financial Services, Aerospace & Defence, Automotive & Transportation, Manufacturing &
Logistics, and Information & Communication Technology.
Engineering a Smarter Future Together.