Global Market Access Regulatory Specialist (Medical Devices)

Location: Ballerup, Denmark

Company

hirify.global develops intelligent hearing, audio, video, and gaming solutions that bring people closer and enhance hearing and sight.

What you will do

• Manage worldwide product registration cases for Class I and IIa medical devices.
• Submit technical file documentation for tenders and reimbursement approval processes.
• Respond to authority questions concerning technical file documentation.
• Act as a Market Access subject matter expert for specific markets.
• Collect and develop technical file documentation, including legalization of documents and Free Sales Certificates.
• Help develop and maintain market access processes, work instructions, templates, quarterly PI planning, and audit activities.

Requirements

• Relevant bachelor's or master's degree, for example in Medical Market Access.
• Experience with worldwide medical device product registration approval processes.
• Knowledge of EU MDR, ISO 13485, and other medical device standards and regulations.
• Strong stakeholder management, collaboration, and communication skills in an international environment.
• High attention to detail and deadlines.
• High-level written and spoken English required.

Nice to have

• Experience with medical device submissions and communication with authorities.
• Experience with project management.

Culture & Benefits

• Work with a market access team of six team members and one student worker at the Ballerup headquarters, plus colleagues in Kazakhstan and China.
• Collaborative team culture with mutual support and clearly defined areas of responsibility.
• Opportunities for professional development and a focus on maintaining a positive daily work environment.
• Inclusive recruitment process with equal consideration for applicants.

Hiring process

• Submit an up-to-date CV and a few sentences explaining motivation.
• Applications are assessed continuously, and the position may close before September 15, 2026, once a preferred candidate is identified.