Associate Director Regulatory Affairs – Vascular (on-site)

Abbott

Westford, MA, United States
Base: $129,300.00 – $258,700.00; bonus/equity: not...
Regulatory submissions preparation
Medical device regulatory knowledge
Leadership of regulatory professionals
Abbott is a global healthcare leader creating breakthrough science to improve people’s health and offers career development with an international company

Job Summary

  • Abbott is a global healthcare leader creating breakthrough science to improve people’s health and offers career development with an international company.
  • The Associate Director, Regulatory Affairs will set strategy and direct preparation of submissions for vascular products, providing regulatory guidance and managing a team.
  • Employees have access to excellent benefits including free medical coverage, retirement savings plans, tuition reimbursement, and a supportive work environment.

Matching Summary

Abbott is a global healthcare leader creating breakthrough science to improve people’s health and offers career development with an international company.

Salary

Base: $129,300.00 – $258,700.00; Bonus/Equity: Not specified; Benefits: Health coverage, retirement savings, tuition reimbursement

Skills & Requirements

Must-have

  • Regulatory submissions preparation
  • Medical device regulatory knowledge
  • Leadership of regulatory professionals
  • Compliance with FDA and international regulations
  • Experience with 510k / PMA submissions
  • Knowledge of IEC standards
  • On-site work in Westford, MA

Nice-to-have

  • Experience with cybersecurity and AI regulations
  • Familiarity with Predetermined Change Control Plans
  • Strong communication with senior management
  • Career development opportunities
  • Diversity and inclusion focus
  • Experience with hardware/software devices

Key Requirements

  • Bachelor’s degree or equivalent experience
  • 5-7 years in regulated industry
  • 5-7 years regulatory experience preferred
  • Preferred advanced degrees (M.S., M.B.A., Ph.D.)
  • RAC certification is a plus
  • Experience with medical device regulatory submissions

Work Rights

Not specified

Tailored Resume

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