Description
An opportunity to direct regulatory affairs in a global, industry-leading, and innovative class II/III medical device company located in Orange County, California. Relocation will be provided for out-of-state candidates.As Director of Regulatory Affairs you will. . .
- Prepare, manage and review submissions for global regulatory approval
- Implement and recommend corporate, division, and organizationally specific policies and procedures to resolve a broad range of problems
- Ensure that team members comply with such policies, practices and procedures within timelines
- Oversee employees responsible for tasks involving regulatory submissions
- Work on numerous product lines, ensuring timely responses and approvals to domestic and international regulatory agencies
- Partner with other regulatory affairs personnel to develop and implement regulatory strategies
- Present to senior management on regulatory related issues
Requirements
- 10 + years of experience in Regulatory Affairs
- Knowledge of FDA regulations and experience with Class II or III medical devices
- Electronic device experience
- Exceptional management/leadership skills
- Strong project management skills, working on multiple products
- BA/BS in scientific, engineering or related field
To find out more about Real please visit www.realstaffing.com