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Halma
Regulatory Affairs Specialist
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Location
Budapest
Work mode
hybrid
Type
full-time
Company size
5,001–10,000 people
First seen
1w ago
Last seen
1d ago
Responsibilities
•
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.
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4+ years Regulatory prior experience, medical device industry highly preferable.
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Extensive knowledge of medical device regulations and standards. (e.g. FDA 21 CFR 820, 803, 806, and 830, MDSAP, MDR, ISO 13485, etc.);
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Product registration knowledge and experience on a worldwide basis;
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Proficient with MS Office, including MS Word, Excel and PowerPoint.
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Excellent organizational and multi tasking skills;
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Ability to work under pressure with strict deadlines;
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Detail-oriented;
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Excellent oral and written communication skills in English;
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Good presentation skills
Nice-to-have
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Knowledge of standards IEC 60601-1, 60601-1-2, 62304, ISO 14971, 10993, 15223-1, 20417
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RoHS/REACH experience preferred
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Fluent in Hungarian
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Further languages
What we offer
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Hybrid/remote work model
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13th month pay
•
Configurable cafeteria package
•
Company laptop and cell phone
Company: #SunTech, #LI-AA4
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