Regulatory Technical Documentation Specialist
Apply today to be considered for this opportunity!
Oslo, 0485 Oslo
Sign in to auto-apply
Job Description
Regulatory Technical Documentation Specialist
For our client, we are currently seeking an experienced and detail-oriented Regulatory Technical Documentation Specialist for an exciting assignment within the medical device industry. This is a unique opportunity for a professional with Clinical Evaluation Report (CER) experience who wants to play a key role in a large-scale regulatory submission for an advanced diagnostic ultrasound system.
Key Responsibilities:
- Drafting, reviewing, and maintaining the Main CER and associated Sub-CERs for a complex ultrasound platform.
- Ensuring consistency between CER documentation, technical requirements, study reports, Instructions for Use (IFUs), and supporting regulatory documentation.
- Collaborating with engineering, regulatory, and clinical teams to gather documentation, resolve gaps, and support project milestones and submission timelines.
This position can be based in either Oslo or Horten and offers a flexible remote working arrangement. The initial assignment is expected to run 3 months.
Requirements
- You hold a relevant degree within life sciences, biomedical engineering, clinical engineering, regulatory affairs, or a related discipline.
- You have proven experience authoring or reviewing Clinical Evaluation Reports (CERs) under EU MDR, MEDDEV, FDA, or NMPA regulatory frameworks.
- You possess experience evaluating technical and clinical documentation, including equivalence assessments and evidence traceability.
- You must already hold a valid residence and work permit for Norway at the time of application.
- You have professional proficiency in written and spoken English.
Skills
Clinical Evaluation Reports (CER)Regulatory AffairsMedical Device DocumentationTechnical WritingQuality AssuranceStakeholder ManagementNMPA/CMDE submission experience
Experience
mid-level