Global Medical Device Regulatory Strategist

eTeam; Diamond Bar (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

eTeam is seeking a Regulatory Affairs professional in Diamond Bar, California. The role involves developing regulatory submissions, authoring documents for international registration, and ensuring compliance with regulations.

The ideal candidate will hold a BS degree in a relevant field and have 4-6 years of Regulatory experience. Excellent communication and project management skills are essential for this position.

Qualifications

• Minimum 4-6 years experience in Regulatory experience or 2-4 years with an advanced degree.
• Must have a solid understanding of regulatory requirements and process.

Responsibilities

• Develop regulatory strategies to ensure timely global commercialization.
• Author regulatory submissions for Class II and III medical devices.
• Directly communicate with FDA and other Regulatory agencies.

Skills

MS Office applications

Excellent communication skills

Project management skills

Problem solving skills

Presentation skills

RAC Certification

Education

BS degree in Engineering, Physical or Biological science

Advanced degree (preferred)

Job description

eTeam is seeking a Regulatory Affairs professional in Diamond Bar, California. The role involves developing regulatory submissions, authoring documents for international registration, and ensuring compliance with regulations.

The ideal candidate will hold a BS degree in a relevant field and have 4-6 years of Regulatory experience. Excellent communication and project management skills are essential for this position.