Regulatory Affairs Specialist
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Before you apply
LocationBudapest
Work modehybrid
Typefull-time
SeniorityMid
Experience4+ yrs
Company size5,001–10,000 people
PostedSep 3, 2026 · 2mo ago
Verified live5d ago
At a glanceSummarised by Seekless from the posting.
Bachelor's Degree required
4+ years Regulatory prior experience
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
Bachelor's Degree in Science focused preferred
Medical device industry experience highly preferable
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
Skills
MS Office
MS Word
MS Excel
MS PowerPoint
Benefits
Remote stipend
Other
Responsibilities
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Provides customer support on regulatory issues;
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Lead CE marking activities (per MDD and EU MDR), including preparation and maintenance of product technical files and clinical evaluations;
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Develops 510K submissions and obtains FDA approval;
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Supports product registrations for many countries on a worldwide basis;
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Monitor and analyze evolving global regulatory requirements and proactively recommend strategies to maintain compliance;
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Support engineering teams in creating and/or updating risk management and FMEA documents for new and existing products;
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Review change requests/engineering changes and provides RA strategy
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Support post-market surveillance activities, ensuring compliance with MDR and other regulatory requirements;
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Participate in internal audits and support external regulatory inspections;
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Provide timely review and approval of product labeling and marketing claims for regulatory compliance;
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Other duties as assigned.
Requirements
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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
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Hybrid/remote work model
•
13th month pay
•
Configurable cafeteria package
•
Company laptop and cell phone
Company: #SunTech,