Specialist Regulatory Affairs

Abbott

Alameda, California, United States
Base: $81,500.00 – $141,300.00; bonus/equity: not ...
Onsite
Review labeling and promotional materials
Coordinate regulatory advertising activities
Support digital product development submissions
Abbott is seeking a Specialist in Regulatory Affairs to join their Diabetes Care Division in Alameda, California. The position involves supporting regulatory processes related to labeling, advertising, and promotional materials, with opportunities to engage in worldwide regulatory submissions and contribute to innovative digital health solutions

Job Summary

  • This role supports the commercialization of new digital products and features including generative AI technologies designed to help millions of patients.
  • The position offers access to free medical coverage, a high employer contribution retirement plan, and tuition reimbursement benefits.
  • You will work out of the Alameda, CA location within the Diabetes Care Division to ensure efficient and compliant business processes.

Matching Summary

Match Score: 85

Abbott is seeking a Specialist in Regulatory Affairs to join their Diabetes Care Division in Alameda, California. The position involves supporting regulatory processes related to labeling, advertising, and promotional materials, with opportunities to engage in worldwide regulatory submissions and contribute to innovative digital health solutions.

Salary

Base: $81,500.00 – $141,300.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings plan, tuition reimbursement

Skills & Requirements

Must-have

  • Review labeling and promotional materials
  • Coordinate regulatory advertising activities
  • Support digital product development submissions
  • Lead junior team members in RA functions
  • Manage cross-functional project timelines

Nice-to-have

  • Experience with diabetes management devices
  • Knowledge of AI and machine learning technologies
  • Strong verbal and written communication skills
  • Ability to negotiate internally with diverse teams
  • Analytical thinking for complex information tracking

Key Requirements

  • Minimum 2 years experience in regulated industry
  • Associates Degree or Bachelor's degree preferred
  • Prior experience with software development teams
  • Knowledge of FDA submission processes (510K, PMA)
  • RAC certification is a plus

Work Rights

Not specified

Tailored Resume

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