Principal Regulatory Affairs Specialist (business Partnerships).

Abbott

Alameda, California, United States
Base: $100,000.00 – $200,000.00; bonus/equity: not...
Onsite
Bachelor's degree in scientific discipline
Experience with regulatory submissions for medical devices
Knowledge of 21 cfr 820 and iso 13485 standards
Abbott is seeking a Principal Regulatory Affairs Specialist to join its Diabetes Care Division in Alameda, California. The role involves developing regulatory strategies for product lifecycle management, particularly focusing on innovative diabetes management solutions and external partnerships

Job Summary

  • This role involves developing global regulatory strategies for strategic business initiatives involving cloud and sensor-based external partnerships within the Diabetes Care Division.
  • The position offers access to comprehensive benefits including free medical coverage, high employer retirement contributions, and tuition reimbursement programs.
  • Candidates will serve as an expert resource interfacing with outside regulatory agencies and providing executive management with regulatory metrics and information.

Matching Summary

Match Score: 85

Abbott is seeking a Principal Regulatory Affairs Specialist to join its Diabetes Care Division in Alameda, California. The role involves developing regulatory strategies for product lifecycle management, particularly focusing on innovative diabetes management solutions and external partnerships.

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

  • Bachelor's Degree in Scientific discipline
  • Experience with regulatory submissions for medical devices
  • Knowledge of 21 CFR 820 and ISO 13485 standards
  • Expertise in US and EU medical device regulations
  • Ability to develop global regulatory strategies

Nice-to-have

  • RAC certification preferred
  • Experience with Class II and III medical devices
  • Strong verbal and written communication skills
  • Ability to work in a matrixed business environment
  • Willingness to travel approximately 5%

Key Requirements

  • Bachelor's Degree in Chemistry, Life Sciences, or Biology
  • Experience with 21 CFR 820, ISO 13485, MDD, and IVD Directives
  • 5 years' experience with Class II/III devices or biologics/drugs (Preferred)
  • Regulatory Affairs Certification (RAC) is a plus
  • Familiarity with 510(k) applications and PMA supplements

Work Rights

Not specified

Tailored Resume

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