Principal Regulatory Affairs Specialist (business Partnerships).

Abbott

Alameda, CA, United States
Base: $86,700.00 – $173,300.00; bonus/equity: not ...
Global regulatory strategy
Product lifecycle management
Regulatory submissions
Develop global regulatory strategies for product development and planning throughout the product lifecycle

Job Summary

  • Develop global regulatory strategies for product development and planning throughout the product lifecycle.
  • Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
  • Abbott is a global healthcare leader that helps people live more fully at all stages of life, offering a comprehensive benefits package and a recognized great place to work.

Matching Summary

Develop global regulatory strategies for product development and planning throughout the product lifecycle.

Salary

Base: $86,700.00 – $173,300.00; Bonus/Equity: Not specified; Benefits: Medical coverage, retirement savings plan, tuition reimbursement

Skills & Requirements

Must-have

  • global regulatory strategy
  • product lifecycle management
  • regulatory submissions
  • on-market changes
  • regulatory compliance strategy
  • business partnership initiatives

Nice-to-have

  • career development opportunities
  • health and wellness benefits
  • diverse work environment
  • cross-divisional business unit model

Key Requirements

  • Bachelor’s Degree in Scientific discipline
  • Experienced in regulatory submissions for Pharmaceutical, IVD, or medical devices
  • Experience with 21 CFR 820, ISO 13485, MDD, or IVDD
  • 5 years experience with Class II/III medical devices or biologics/drugs
  • Experience with 510(k) applications, PMA supplements, US device regulations
  • Experience with EU and international medical device regulations

Work Rights

Not specified

Tailored Resume

Cover Letter