Epic Documentation & Compliance Specialist

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

Are you ready to help ensure compliant, well-structured documentation for software that supports people with hearing loss? We are looking for an Epic Documentation & Compliance Specialist to support Design Control activities across medical device software projects within GN Hearing.In the role of **Epic Documentation & Compliance 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 encourage you to apply** Even if you do not match all the above-mentioned skills, we welcome your application if you think you have transferable skills. 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.**How to apply?** Use the ‘APPLY’ link no later than **September 28.** Applications are assessed continuously, so do not wait to send yours. Feel free to only submit your up-to-date CV, including a few sentences outlining your motivation for applying – quick and easy.**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.**