Associate Principal, Regulatory Affairs

Location

Aliso Viejo, California, USA

Department Name

523-RAQA Regulatory

Qualifications

1. Bachelor's degree in a scientific or technical discipline or relevant field of study. 
2. Minimum five (5) years of relevant professional regulatory experience. 
3. Strong technical writing skills as evidence by successful US FDA Class II / III medical device submissions, EU CE Mark applications, Health Canada submissions and/or rest of the world (ROW) registrations across product lines. 
4. Prior direct involvement interfacing with regulatory authorities through various stages of device life cycle. 
5. Detail oriented.
6. Strong written and verbal communication skills. 
7. Proficient computer skills, including MS Word, Excel, Outlook, and Teams. 

1. Advanced degree in a scientific or technical discipline or relevant field of study. 
2. Experience in leading medium to large sized teams. 
3. Ability to work well in a team environment.
4. Proven analytical abilities and organization skills. 
5. Ability to comprehend technical documents and concepts.

External-Facing Title

Associate Principal, Regulatory Affairs

Posting Country

US - United States

Salary Range

$110,000 - $130,000 (salary could be higher based on education, experience or skill set)