Responsibilities

• Plans and organizes registration packages. Prepares registration packages in line with local regulatory requirements and guidelines.
• Evaluates manufacturing and labeling changes, and promotional materials for regulatory impact with guidance. Accurately describes these changes for ease of regulatory agency review.
• 510(k) / Q-sub /Quality Submission/ Response experience
• MDR Technical Documentation experience
• Able to follow scientific arguments.
• Ability to prioritize key business objectives and respond quickly to changing priorities Ability to work independently with minimal daily instruction

Education and Experience:

• Bachelor’s degree from an accredited college or university is required, Masters preferred
• Three to five years of experience in Regulatory Affairs, Research, Development or related area.

Job Type: Contract

Pay: $34.00 - $39.00 per hour

Expected hours: 40 per week

Schedule:

• 8 hour shift
• Monday to Friday

Experience:

• Regulatory Affairs: 3 years (Preferred)
• 510 (K) Submission: 3 years (Required)

Ability to Commute:

• San Diego, CA (Required)

Work Location: In person