About This Role
This role involves ensuring that the company's medical devices meet global regulatory requirements and supporting product development and post-market activities. The specialist will handle CE marking, FDA submissions, and worldwide product registrations, while also monitoring evolving regulations and providing strategic recommendations.
Responsibilities
- Provide 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
- Develop 510K submissions and obtain FDA approval
- Support 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 provide 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
- Perform other duties as assigned
Requirements
- Bachelor's Degree required; Science focused preferred
- 4+ years of prior regulatory 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 multitasking 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
Benefits
- 13th month pay
- Configurable cafeteria package
- Company laptop and cell phone
Important Details
- Work format: hybrid/remote work model
About the Company
SunTech is the company hiring for this role.
