Job Summary
An information technology company has an open position for a Remote Regulatory Affairs Consultant in Gainesville.
Must be able to:
- Develop and prepare product registration submissions for the US, Canada, EU and select worldwide locations
- Identify potential regulatory approvals risks based on changes in regulations
- Review and approve engineering changes, advertising, promotional items and labeling
Position Requirements Include:
- Minimum 15 years professional experience in the applicable role
- Bachelor's /Master's degree or equivalent
- Familiarity with product clearances, establishing licenses, maintaining files
- Knowledge of evolving regulatory landscape, quality system procedures
- Ability to advise internal stakeholders on current/pending guidance, regulations
- Ability to provide significant regulatory support to ongoing PMA activities
