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: SunTech Medical; #LI-AA4