Medical Device Software Design Control Lead

GN Group; Denmark; Hybrid; DKK 650,000 - 900,000; Full time

Job summary

GN Hearing is seeking an Epic Documentation & Compliance Specialist to drive Design Control documentation across medical device software projects within the Software Solutions R&D team. You will coordinate and maintain design control documentation and processes, aligning with the corporate QMS and IEC 62304.

You will support GDPR and cybersecurity assessments, contribute to CE/ FDA submissions, and help improve templates, traceability and AI-assisted documentation practices.

Qualifications

• Experience with Design Control for medical devices, preferably within software development.
• Knowledge of ISO 13485, 21 CFR 820.30, ISO 14971 and IEC 62304.

Responsibilities

• Plan, coordinate and support completion of Design Control deliverables for medical device and non-medical software platforms.
• Coordinate Design Control activities throughout the software development lifecycle in accordance with the corporate QMS and IEC 62304.
• Review, prepare and maintain Design Control documentation, including development plans, requirements, system documentation, risk management files and labelling documentation.
• Support change requests, defect triage, GDPR and cybersecurity assessments, ensuring related work items contain complete and compliant information.
• Prepare and coordinate Design Reviews with project teams, following up on documentation status, actions, dependencies and agreed plans.
• Support technical documentation for CE Technical Files and FDA submissions and contribute during audits when needed.
• Improve Design Control processes, templates, checklists, traceability and documentation practices, including pragmatic use of AI-supported documentation and review methods.

Skills

Design Control

ISO 13485

IEC 62304

GDPR

Cybersecurity assessments

Job description

GN Hearing is seeking an Epic Documentation & Compliance Specialist to drive Design Control documentation across medical device software projects within the Software Solutions R&D team. You will coordinate and maintain design control documentation and processes, aligning with the corporate QMS and IEC 62304.

You will support GDPR and cybersecurity assessments, contribute to CE/ FDA submissions, and help improve templates, traceability and AI-assisted documentation practices.