We are looking to hire a skilled professional to handle our medical device regulatory affairs department. This person will play a crucial role in ensuring that our medical devices comply with all applicable regulatory requirements and standards under MDR.
The person will be responsible for preparing and submitting regulatory applications, communicating with regulatory authorities, and providing guidance and training to cross-functional teams. Will be also responsible for a wide range of tasks, from preparing regulatory filings to monitoring changes in regulations.
The responsibilities include but not limited:
- Ensuring medical devices comply with all applicable regulatory requirements and standards
- Preparing and submitting regulatory applications, including 510(k) and MDR submissions and PMA applications
- Communicating with regulatory authorities, such as the FDA, Notified Bodies to respond to inquiries and negotiate compliance
- Monitoring and staying up-to-date on changes in domestic and international medical device regulations
- Providing guidance and training to cross-functional teams on regulatory requirements
- Assisting in the development of regulatory strategies and compliance initiatives
- Maintaining thorough documentation and records to demonstrate regulatory compliance
Pay: $25.00 - $32.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Health insurance
- Paid time off
Work Location: In person
