Regulatory Affairs Manager (Medical Devices, Smørum)

Job summary

This role involves overseeing regulatory compliance for sound processors, software, and accessories in the medical device sector, ensuring patient safety and adherence to regulatory standards throughout the product lifecycle.

Qualifications

• Minimum of 3 years of experience in Regulatory Affairs or Quality within the medical devices industry.
• In-depth knowledge of EU MDR, ISO 13485, MDSAP, and FDA QSR.
• Technical expertise in active medical devices, particularly in software, cybersecurity, electrical safety, and EMC.
• Strong communication skills and ability to engage with diverse stakeholders.
• Fluent in English.
• Willingness to travel approximately 10 days per year.
• Must be able to work from Smørum from the start.

Responsibilities

• Act as the primary regulatory authority for product development and lifecycle management.
• Define regulatory strategies and represent Quality Assurance and Regulatory Affairs (QARA) in cross-functional projects.
• Guide development teams on Quality Management System (QMS) and regulatory compliance.
• Establish and maintain Technical Documentation and Technical Files.
• Lead risk management activities and CE marking under MDR and FDA submissions.
• Review product claims for labeling, instructions for use (IFUs), and marketing materials.
• Oversee type approvals, including radio/wireless approvals and software/cybersecurity compliance.

Skills

• Pragmatic, product-focused mindset with the ability to translate regulatory requirements into actionable solutions.
• Effective stakeholder engagement and communication skills.

Education

• Relevant degree in a scientific or engineering discipline is preferred but not specified.

Tools

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