About this role
Responsibilities
• Provides customer support on regulatory issues; • Lead CE marking activities (per MDD and EU MDR), including preparation and maintenance of product technical files and clinical evaluations; • Develops 510K submissions and obtains FDA approval; • Supports product registrations for many countries on a worldwide basis; • Monitor and analyze evolving global regulatory requirements and proactively recommend strategies to maintain compliance; • Support engineering teams in creating and/or updating risk management and FMEA documents for new and existing products; • Review change requests/engineering changes and provides RA strategy • Support post-market surveillance activities, ensuring compliance with MDR and other regulatory requirements; • Participate in internal audits and support external regulatory inspections; • Provide timely review and approval of product labeling and marketing claims for regulatory compliance; • Other duties as assigned. Requirements
• A Bachelor's Degree required; Science focused preferred. • 4+ years Regulatory prior experience, medical device industry highly preferable. • Extensive knowledge of medical device regulations and standards. (e.g. FDA 21 CFR 820, 803, 806, and 830, MDSAP, MDR, ISO 13485, etc.); • Product registration knowledge and experience on a worldwide basis; • Proficient with MS Office, including MS Word, Excel and PowerPoint. • Excellent organizational and multi tasking skills; • Ability to work under pressure with strict deadlines; • Detail-oriented; • Excellent oral and written communication skills in English; • Good presentation skills Nice-to-have
• Knowledge of standards IEC 60601-1, 60601-1-2, 62304, ISO 14971, 10993, 15223-1, 20417 • RoHS/REACH experience preferred • Fluent in Hungarian • Further languages What we offer
• Hybrid/remote work model • 13th month pay • Configurable cafeteria package • Company laptop and cell phone
Company: #SunTech, #LI-AA4