Regulatory Affairs Specialist Ii – Cardiac Rhythm Management (on-site)

Abbott

Sylmar, California, United States
Base: $81,500.00 – $141,300.00; bonus/equity: not ...
On-site
Bachelor's degree or equivalent experience
Minimum 2 years regulated industry experience
Strong verbal and written communication skills
Abbott is seeking a Regulatory Affairs Specialist II for their Cardiac Rhythm Management division in Sylmar, California. The ideal candidate will have at least two years of experience in a regulated industry and will be responsible for preparing regulatory applications, ensuring compliance with FDA and international regulations, and supporting product market entry

Job Summary

  • This role involves preparing robust regulatory applications for the FDA and international agencies to achieve organizational objectives.
  • The position offers access to career development, free medical coverage, a high employer contribution retirement plan, and tuition reimbursement.
  • Candidates will support the product release process by creating GTS licenses and reviewing protocols to ensure compliance with global regulations.

Matching Summary

Match Score: 85

Abbott is seeking a Regulatory Affairs Specialist II for their Cardiac Rhythm Management division in Sylmar, California. The ideal candidate will have at least two years of experience in a regulated industry and will be responsible for preparing regulatory applications, ensuring compliance with FDA and international regulations, and supporting product market entry.

Salary

Base: $81,500.00 – $141,300.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings plan, tuition reimbursement

Skills & Requirements

Must-have

  • Bachelor's degree or equivalent experience
  • Minimum 2 years regulated industry experience
  • Strong verbal and written communication skills
  • Ability to work in fast-paced matrixed environment

Nice-to-have

  • Experience working in medical device industry
  • Regulatory Affairs Professionals Society Certification
  • Ability to negotiate internally
  • Experience with cross-functional teams

Key Requirements

  • Bachelor's degree required
  • 2 years minimum experience in regulated industry
  • Knowledge of FDA and international medical device regulations preferred

Work Rights

Not specified

Tailored Resume

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