Documentation & Compliance Lead — Medical Device Software

GN Group; Ballerup; Hybrid; DKK 600,000 - 900,000; Full time

Job summary

GN Group's GN Hearing division seeks a Software Design Control Specialist to coordinate and maintain Design Control documentation across medical device software projects. You will align activities with the corporate QMS, IEC 62304 and relevant regulatory requirements while collaborating with cross-functional teams to ensure safe, compliant software solutions.

The role emphasizes planning, documentation discipline and continuous improvement, with opportunities to contribute during audits and

Qualifications

• Experience with Design Control for medical devices, preferably in software development.
• Knowledge of ISO 13485, 21 CFR 820.30, ISO 14971 and IEC 62304.
• Experience with GDPR, cybersecurity assessments, AAMI TIR45 and Agile medical device software practices.
• Structured approach to planning, documentation and follow-up with emphasis on quality.
• Clear communication across disciplines, cultures and levels.

Responsibilities

• Plan, coordinate and support completion of Design Control deliverables for medical device software.
• Coordinate Design Control activities throughout the software development lifecycle per QMS and IEC 62304.
• Review, prepare and maintain Design Control documentation (plans, requirements, system docs, risk files, labelling).
• Support change requests, GDPR and cybersecurity assessments; ensure compliant information.
• Prepare and coordinate Design Reviews with project teams and track status and actions.
• Support CE Technical Files and FDA submissions; contribute during audits as needed.
• Improve Design Control processes, templates, checklists, traceability and documentation practices, including AI-supported methods.

Skills

Design Control

Regulatory knowledge

Documentation management

Cross-functional collaboration

Job description

GN Group's GN Hearing division seeks a Software Design Control Specialist to coordinate and maintain Design Control documentation across medical device software projects. You will align activities with the corporate QMS, IEC 62304 and relevant regulatory requirements while collaborating with cross-functional teams to ensure safe, compliant software solutions.

The role emphasizes planning, documentation discipline and continuous improvement, with opportunities to contribute during audits and