Regulatory Affairs Specialist
Halma · Budapest
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, #LI-AA4