Regulatory Affairs Manager - International Compliance Operations – Diabetes Care (on-site)

Abbott

Alameda, CA, US
Base: $114,000.00 – $228,000.00; bonus/equity: not...
On-site
8 years medical device industry experience
5 years fda submission preparation
Class i ii iii device regulatory knowledge
Abbott is seeking a Regulatory Affairs Manager for its Diabetes Care Division in Alameda, CA. The role focuses on ensuring compliance with international regulations for medical devices, requiring significant experience in regulatory submissions and collaboration with cross-functional teams

Job Summary

  • This role provides end-to-end support for the regulatory department to ensure efficient and compliant business processes within the Diabetes Care Division.
  • The position involves leading SOP development, assessing documentation for gap assessments, and coordinating change implementation via approved mechanisms.
  • Abbott offers comprehensive benefits including free medical coverage in the Health Investment Plan, a high employer contribution retirement plan, and tuition reimbursement.

Matching Summary

Match Score: 85

Abbott is seeking a Regulatory Affairs Manager for its Diabetes Care Division in Alameda, CA. The role focuses on ensuring compliance with international regulations for medical devices, requiring significant experience in regulatory submissions and collaboration with cross-functional teams.

Salary

Base: $114,000.00 – $228,000.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings plan, tuition reimbursement

Skills & Requirements

Must-have

  • 8 years medical device industry experience
  • 5 years FDA submission preparation
  • Class I II III device regulatory knowledge
  • Scientific writing experience required
  • QSR ISO EN standards working knowledge
  • European Japan Canada regulatory requirements

Nice-to-have

  • Experience with Veeva Vault systems
  • AI assisted process improvement skills
  • Light automation dashboard building
  • Small team management experience
  • RAC PMP Lean Six Sigma certification
  • Matrixed geographically diverse environment

Key Requirements

  • Bachelor's degree or equivalent combination of education and work experience
  • Minimum 8 years experience in medical device industry
  • 5 years related to FDA submissions (PMA IDE 510k)
  • Working knowledge of QSR ISO and EN standards
  • Strong verbal and written communication skills

Work Rights

Not specified

Tailored Resume

Cover Letter