Regulatory Affairs Specialist

• 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.

• A Bachelors 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 CFRand 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

• Knowledge of standards IECISO 15223-1 20417
• RoHS/REACH experience preferred
• Fluent in Hungarian
• Further languages

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

Company: #SunTech #LI-AA4