Sr. Specialist, Regulatory Affairs

Location

Aliso Viejo, California, USA

Department Name

1620-Regulatory SMI

Qualifications

1. Bachelor’s degree in a scientific or technical discipline or relevant field of study. 
2. Minimum four (4) years of relevant professional regulatory experience. 
3. Strong technical writing skills as evidenced by successful U.S. FDA Class II / III medical device submissions, EU CE Mark applications, Health Canada submissions, and/or the rest of the world (ROW) registrations. 
4. Experience interfacing with regulatory authorities through various stages of device life cycle. 
5. Strong attention to detail.
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 small to medium sized teams. 
3. Ability to work well in a team environment. 
4. Strong technical writing skills. 
5. Proven analytical abilities and organization skills. 
6. Ability to comprehend technical documents and concepts.

External-Facing Title

Sr Specialist, Regulatory Affairs

Posting Country

US - United States

Salary Range

$95,000 - $115,000 (salary could be higher based on education, experience or skill set)