Offer summary
Qualifications:
Bachelor's degree in Science, Engineering or Regulatory, 3-5 years of experience in regulated manufacturing, Experience with FDA and global regulatory bodies preferred, Master's in Regulatory Affairs preferred, Knowledge of Class III and implantable devices.
Key responsabilities:
- Develop and implement processes for licenses and registrations
- Review advertising to ensure regulatory compliance
- Submit updates to product information and instructions for use
- Provide regulatory guidance for product development and lifecycle
- Train stakeholders on regulatory requirements