About This Role
This role focuses on ensuring that the company's medical devices meet global regulatory requirements and standards. The specialist will handle CE marking, FDA submissions, and product registrations worldwide, while also monitoring evolving regulations to maintain compliance.
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 or remote work model
About the Company
SunTech Medical is the company hiring for this role.
