Software Compliance Expert – Medical Devices & Cybersecurity

MagVenture, Farum, Denmark

MagVenture is a pioneer in Transcranial Magnetic Stimulation (TMS), offering market-leading FDA-approved solutions for both therapeutic and research applications. With around 200 employees and operations in more than 60 countries, we are rapidly expanding and committed to developing innovative medical devices that make a real difference in people’s lives.

As a global leader in medtech, MagVenture’s TMS technology is transforming treatments for severe depression, OCD, and other complex conditions. As we continue to expand into new therapeutic areas like Parkinson’s, PTSD, and dementia, we are seeking a Compliance Expert to join our team and ensure we adhere to the rigorous standards required for medical device software and cybersecurity

The Role
As Compliance Expert, you will ensure that our software and systems meet the required regulatory and cybersecurity standards. Working closely with the software development and R&D teams, you will create a secure and compliant environment for our medical devices. Your focus will be on maintaining adherence to medical device regulations, cybersecurity protocols, and ensuring all documentation is in place.

This role will involve implementing development procedures, guiding compliance, and managing risk and cybersecurity practices across projects. We provide training and support for specific standards if needed, so candidates with a solid foundation but limited exposure to certain areas are encouraged to apply.

Key Responsibilities

• Develop and implement control procedures aligned with relevant medical and cybersecurity standards
• Ensure processes and documentation meet FDA, MDR, and other regulatory requirements
• Implement best practices for cybersecurity and patient data protection
• Lead the creation, review, and organization of documentation related to cybersecurity and software product lifecycle
• Integrate risk identification and mitigation processes into the software systems
• Assist in preparing for regulatory submissions and audits
• Provide support and guidance to R&D on regulatory and cybersecurity practices

Ideal Candidate Profile

• PhD, MSc or BSc in a scientific/medical discipline and/or relevant certifications
• Expertise in medical device standards (e.g., IEC 62304, ISO 13485, ISO 14971) and medical device compliance
• Familiarity with cybersecurity standards and data protection regulations (e.g., ISO/IEC 27001, IEC 81001-5-1, HIPAA, GDPR)
• Strong documentation management skills to ensure full regulatory traceability and compliance
• Organizational skills to manage compliance processes and meet regulatory deadlines
• Experience with regulatory submissions and managing audits
• Strong collaboration and communication skills, engaging effectively with stakeholders for project alignment
• Comfortable in an agile environment, able to take initiative and adapt to evolving project needs
• Takes responsibility for tasks and works independently with minimal supervision
• A collaborative spirit, thriving in teamwork
• Fluent in English (written and spoken); Danish is an advantage
• Based in the Copenhagen area with a valid work and residence permit

What MagVenture Offers
MagVenture is an innovative and purpose-driven company where you will have the opportunity to help shape the future of medical technology. As a Compliance Expert, we offer:

• A central role in ensuring compliance with international standards
• The chance to work with a passionate team dedicated to improving patient outcomes
• A flexible and supportive work environment with opportunities for growth

• Benefits including flexible hours, pension scheme, lunch arrangement, and health insurance
• A workplace that fosters creativity and inclusivity

Want to Join?
We are hiring on an ongoing basis, so please don’t hesitate to click the "Apply" button to join our team. We review applications continuously and conduct interviews on an ongoing basis. The posting will close once we have the right candidate.

For more information or questions, please contact Software Team Lead Ask Møller at [email protected] or +45 2928 3035.

Job location:
Farum

Application deadline:
Ongoing

If you have any questions, please contact

Ask Møller
Software Team Lead

[email protected]

29 28 30 35