Regulatory Affairs Specialist

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: #Sun.

Tech, #LI-AA4