Principal International Regulatory Product Specialist - Diabetes Care (on-site)

Abbott

Alameda, California, United States
Base: $100,000.00 – $200,000.00; bonus/equity: not...
On-site
Bachelor's degree in scientific discipline
Experience with 21 cfr 820 and iso 13485
Knowledge of medical devices directive 93/42/eec
Abbott is seeking a Principal International Regulatory Product Specialist for its Diabetes Care division in Alameda, California. The role involves providing regulatory expertise, ensuring compliance with global regulations, and contributing to product lifecycle planning

Job Summary

  • This role involves providing subject-matter expertise to ensure efficient and compliant business processes within the Diabetes Care Division.
  • The company offers excellent benefits including free medical coverage, a high employer contribution retirement plan, and tuition reimbursement.
  • The position requires coordinating with regional regulatory affairs teams to update submission strategies in response to changing regulations.

Matching Summary

Match Score: 85

Abbott is seeking a Principal International Regulatory Product Specialist for its Diabetes Care division in Alameda, California. The role involves providing regulatory expertise, ensuring compliance with global regulations, and contributing to product lifecycle planning.

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 21 CFR 820 and ISO 13485
  • Knowledge of Medical Devices Directive 93/42/EEC
  • Experience with IVD Directive 98/79/EC
  • Expertise in regulatory submissions for medical devices

Nice-to-have

  • RAC certification from Regulatory Affairs Professionals Society
  • Advanced level degree in science or engineering
  • Proficiency with Veeva Vault and dashboarding tools
  • Experience in highly matrixed global business environments
  • Strong cross-functional collaboration skills

Key Requirements

  • Bachelor's Degree in Chemistry, Life Sciences, or Biology
  • Experience with EU and international medical device regulations
  • 2-3 years of experience in regulatory submissions preferred
  • Understanding of design controls in medical devices and IVDR
  • Ability to work on-site in Alameda, CA

Work Rights

Not specified

Tailored Resume

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