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