Regulatory Affairs Specialist – Medical Devices

About the role

Halma is looking for a Regulatory Affairs Specialist in Budapest to support its medical device business. The role covers customer support on regulatory issues, CE marking, 510(k) submissions, product registrations worldwide and compliance monitoring.

Key responsibilities

• Provide customer support on regulatory issues
• Lead CE marking activities (MDD and EU MDR), including preparation and maintenance of technical files and clinical evaluations
• Develop 510(k) submissions and obtain FDA approval
• Support product registrations in many countries worldwide
• Monitor evolving global regulatory requirements and recommend compliance strategies
• Support engineering teams in creating and updating risk management and FMEA documents, and review change requests
• Support post-market surveillance and ensure compliance with MDR and other requirements
• Take part in internal audits and support external regulatory inspections
• Review and approve product labeling and marketing claims

Required profile

• Bachelor's degree; science focus preferred
• 4+ years of regulatory experience; medical device industry highly preferable
• Extensive knowledge of medical device regulations and standards (FDA 21 CFR 820, 803, 806, 830, MDSAP, MDR, ISO 13485)
• Worldwide product registration experience
• Excellent English, oral and written, with good presentation skills
• Nice to have: fluency in Hungarian and further languages

Required skills

• MS Office (Word, Excel, PowerPoint)
• Organizational and multitasking skills, ability to work under pressure with strict deadlines
• Detailed, detail-oriented approach

What we offer

• Hybrid/remote work model
• 13th month pay
• Configurable cafeteria package
• Company laptop and cell phone