Epic Documentation & Compliance Specialist

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

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.

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.

Requirements

• 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 highly value a mindset and motivation that align with our core values, to not only ensure growth for you, but for your team and the wider GN organization as well.

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.

About GN

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.

#LI-GNGroup GN brings people closer through our leading intelligent hearing, audio, video, and gaming solutions. Inspired by people and driven by innovation, we deliver technology that enhance the senses of hearing and sight. We help people with hearing loss overcome real-life challenges, improve communication and collaboration for businesses, and provide great experiences for audio and gaming enthusiasts.

GN was founded more than 150 years ago with a vision to connect the world. Today, inspired by our strong heritage, GN touches more lives than ever with the broadest portfolio of products and services in our history - fostering a sense of community, openness, and understanding. By listening to customers and combining our unique expertise in the human ear, audio, video, and speech, wireless technologies, software, and miniaturization, we transform what it takes to bring people closer to what is important to them.

The GN-owned brands that are responsible for bringing these technologies to life: Medical grade hearing technology: ReSound, Beltone, Interton, Jabra Professional collaboration: Jabra, BlueParrott, FalCom Gaming, calls and media: SteelSeries, Jabra

Founded in 1869, the GN Group employs 7,000 people and is listed on Nasdaq Copenhagen (GN.CO). GN's solutions are sold in around 100 countries across the world.

If you would like to learn more about us, visit our homepage gn.com or click on our different brands. You can also connect with you on LinkedIn, Facebook and Twitter.