Senior Regulatory Affairs Specialist

Baltgroup

Irvine, United States
Base: $125,000 - $130,000 usd; bonus/equity: not s...
On-site
Regulatory strategy development
Global regulatory submissions
Fda/notified body interaction
Baltgroup is seeking a Senior Regulatory Affairs Specialist to manage regulatory submissions for medical devices and collaborate with cross-functional teams. The ideal candidate will have experience with various regulatory applications and thrive in a dynamic work environment

Job Summary

  • The Senior Regulatory Affairs Specialist is responsible for the coordination and preparation of regulatory submissions for new and modified medical devices, license renewals, and annual registrations.
  • Develop and implement complex, global regulatory strategies and represent Regulatory Affairs on project teams, partnering with cross-functional teams to ensure alignment.
  • Balt is a rapidly growing pioneer in an exceptional field, collaborating with physicians and institutions to develop elegant medical devices for 45 years.

Matching Summary

Match Score: 85

Baltgroup is seeking a Senior Regulatory Affairs Specialist to manage regulatory submissions for medical devices and collaborate with cross-functional teams. The ideal candidate will have experience with various regulatory applications and thrive in a dynamic work environment.

Salary

Base: $125,000 - $130,000 USD; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Regulatory strategy development
  • Global regulatory submissions
  • FDA/Notified Body interaction
  • Device labeling review
  • Advertising and promotion compliance

Nice-to-have

  • Pride in work
  • Multicultural community
  • Making a difference
  • Teamwork and collaboration

Key Requirements

  • Experience with HDE, IDE, 510k, and PMA applications
  • Project management skills
  • Ability to work under pressure
  • Works well in a team environment

Work Rights

Not specified

Tailored Resume

Cover Letter