Senior Regulatory Affairs Specialist (Medical Devices, Copenhagen)

Job summary

The role involves ensuring compliance with regulatory requirements for innovative medical device software solutions and intraoral scanners, including AI devices. The specialist will contribute regulatory expertise from the early stages of development through to market release planning and registration.

Qualifications

• Master’s degree in natural sciences, computer science, engineering, or a related field.
• 5-10+ years of experience in regulatory affairs, ideally with both software and hardware medical devices.
• Experience with global regulatory markets, including EU, UK, Switzerland, and MDSAP.
• Proven ability to apply and interpret relevant guidance and standards for medical devices, such as IEC 60601 series, ISO 14971, IEC 62304, and IEC 82304.
• Strong understanding of cybersecurity and regulations for digital health and AI/ML devices.
• Adaptability to changes in agile work environments and a global mindset with experience in multicultural work relations.

Responsibilities

• Collaborate with stakeholders across R&D, Marketing, Product Management, and sales to ensure regulatory compliance.
• Provide regulatory input during the development and market release phases of medical devices.
• Engage with external advisors and regulatory consultants to facilitate global device registrations.
• Participate in advocacy efforts and industry forums to influence policy and regulatory frameworks.

Skills

• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills for collaboration with diverse teams.

Education

• Master’s degree in a relevant field.

Tools

• Familiarity with regulatory compliance tools and software relevant to medical devices.