Software Design Control Specialist, Hearing

GN Group; Ballerup; Hybrid; DKK 700,000 - 900,000; Full time

Job summary

GN Hearing is seeking a Software Design Control Specialist to support Design Control activities and Epic Documentation across medical device software projects. You will coordinate and maintain Design Control documentation and processes within GN Hearing’s Software Solutions R&D team.

You will ensure compliance with quality management requirements and medical device regulations, collaborating with global teams and contributing to CE and FDA documentation efforts and audits.

Qualifications

• Bring experience with Design Control for medical devices
• 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.

Job description

Are you ready to help ensure compliant, well-structured documentation for software that supports people with hearing loss? We are looking for Software Design Control Specialist to support Design Control activities and Epic Documentation across medical device software projects within GN Hearing.

In the role of Software Design Control Specialist in the Software Solutions R&D team, you will coordinate and maintain Design Control documentation and processes, helping project teams develop software solutions in line with quality management requirements and medical device regulations.

The Team you will be part of

You will join Software Solutions R&D in GN Hearing, working closely with Corporate Quality and cross-functional project teams. The team develops software solutions that support our hearing care products and services.

We work collaboratively across disciplines, countries and functions to translate regulatory requirements into practical, efficient ways of working. We value clear communication, careful planning and continuous learning as we support the delivery of safe and compliant solutions.

Your contribution is appreciated, and you will:

• 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.

To perform well in the role, we imagine that you:

• Bring experience with Design Control for medical devices, preferably within software development.
• Have knowledge of relevant standards and regulations, such as ISO 13485, 21 CFR 820.30, ISO 14971 and IEC 62304.
• May have experience with GDPR, cybersecurity assessments, AAMI TIR45 and Agile medical device software development practices.
• Bring a structured approach to planning, documentation and follow-up, with attention to quality outcomes.
• Communicate clearly and work well with others across technical disciplines, cultures and organisational levels.

At GN we pride ourselves on encouraging flexible work whenever possible. We trust our people to fulfill their responsibilities, to know when in-person collaboration is better than hybrid, and to be present when it's needed most.

We are focused on an inclusive recruitment process

All applicants will receive equal consideration for employment. As such, we encourage you to submit your CV without a photo to ensure an equal and fair application process.

Should you have any special requirements for the interview, please let the Hiring Manager know upon accepting the invitation to the interview.

Join us in Bringing People Closer

GN brings people closer through our advanced intelligent hearing, audio, video, and gaming solutions. Inspired by people and motivated by innovation, we deliver technology that enhances the senses of hearing and sight. We enable people with hearing loss to overcome real-life problems, improve communication and collaboration for businesses, and provide great experiences for audio and gaming users.

GN Store Nord A/S has entered into a definitive agreement for the sale of GN’s Hearing business to Amplifon S.p.A. to create a global leader in audiology. Read more about the announcement here.

We hope you will join us on this journey and look forward to receiving your application.