Principal Regulatory Affairs Specialist – Diabetes Care (on-site)

Abbott

Alameda, CA, United States
Base: $100,000.00 – $200,000.00; bonus/equity: not...
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Us regulatory submissions experience
In vitro diagnostic devices knowledge
21 cfr 820 compliance expertise
** Abbott is seeking a Principal Regulatory Affairs Specialist for its Diabetes Care Division, focusing on US submissions for new product introductions, particularly in continuous glucose monitoring systems. The role demands extensive expertise in regulatory submissions, compliance, and strategic development within a collaborative team environment. **

Job Summary

  • Abbott is a global healthcare leader focused on revolutionizing glucose monitoring with new sensing technology for people with diabetes.
  • The Principal Regulatory Affairs Specialist will develop global strategies for premarket submissions of continuous glucose monitoring systems.
  • Employees qualify for free medical coverage in the Health Investment Plan, high employer retirement contributions, and tuition reimbursement benefits.

Matching Summary

Match Score: 75

** Abbott is seeking a Principal Regulatory Affairs Specialist for its Diabetes Care Division, focusing on US submissions for new product introductions, particularly in continuous glucose monitoring systems. The role demands extensive expertise in regulatory submissions, compliance, and strategic development within a collaborative team environment. **

Salary

Base: $100,000.00 – $200,000.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings plan, tuition reimbursement

Skills & Requirements

Must-have

  • US regulatory submissions experience
  • In Vitro Diagnostic Devices knowledge
  • 21 CFR 820 compliance expertise
  • ISO 13485 standards application
  • Medical Device Regulation familiarity

Nice-to-have

  • Cross-division business unit model experience
  • Matrixed and geographically diverse environment
  • Strong verbal and written communication skills
  • Ability to work independently with little oversight
  • Experience with crisis/issue management programs

Key Requirements

  • Bachelor's Degree in Scientific discipline
  • Experience with Class II or Class III medical devices
  • Regulatory Affairs Certification (RAC) preferred
  • 5 years' experience working with biologics/drugs
  • Familiarity with EU and International Medical Device Regulations

Work Rights

Not specified

Tailored Resume

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