Regulatory Affairs Specialist (MedTech)

Location: Warsaw, Poland; hybrid work with four days per week in the office and one day remotely

Company

hirify.global develops precision radiation medicine and radiotherapy solutions used by healthcare providers in more than 130 countries.

What you will do

• Coordinate regulatory blocking and release activities for assigned products and spare parts.
• Maintain blocked and unblocked product status in ERP systems.
• Review release forecasts, identify risks, and support corrective actions to ensure product availability.
• Provide regulatory information for customer orders, spare-parts releases, and business decisions.
• Monitor and report on block and release process performance.
• Collaborate with cross-functional stakeholders and improve regulatory processes, tools, and catalogue content.

Requirements

• Experience in a regulated industry, preferably medical devices, healthcare, pharmaceuticals, or life sciences.
• Understanding of compliance, quality, and regulatory requirements in a global environment.
• Experience with ERP systems and business processes.
• Proficiency in Microsoft Office, including Word, Excel, Outlook, and Teams.
• Strong attention to detail, communication, prioritization, accountability, and problem-solving skills.
• Ability to collaborate with technical and non-technical teams and implement practical process improvements.

Culture & Benefits

• Private medical care through Medicover.
• Group life insurance and a Multikafeteria benefits platform with access to the Multisport card.
• Employee Pension Plan after successful completion of the probation period.
• Employee Assistance Program providing psychological and legal support.
• Glasses reimbursement, employee discounts, and an employee referral program after probation.

Hiring process

• Submit a CV in English through the application platform.
• Applications are reviewed on an ongoing basis.