Principal Clinical Safety Specialist- Shockwave Medical (remote)

J&J FAMILY OF COMPANIES

Minnesota, United States of America
Base: $125,000.00 - $201,250.00; bonus/equity: eli...
Fully remote
Clinical safety management
Adverse event reporting
Medical device clinical studies
Johnson & Johnson is seeking a Principal Clinical Safety Specialist for their Shockwave Medical team, a fully remote position focused on clinical safety oversight in medical device studies, particularly for cardiovascular diseases. The ideal candidate will have extensive experience in clinical safety, specifically within the medical device sector, and will play a crucial role in ensuring compliance and high-quality safety data collection

Job Summary

  • The Principal Clinical Safety Specialist will have primary responsibility for study or program oversight, ensuring all aspects of safety are conducted according to procedure and in a compliant manner.
  • Johnson & Johnson provides an inclusive work environment respecting diversity and dignity of employees and offers comprehensive benefits including retirement plans, paid time off, and parental leave.
  • The role supports the development and commercialization of Intravascular Lithotripsy (IVL) technology to treat complex calcified cardiovascular disease.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking a Principal Clinical Safety Specialist for their Shockwave Medical team, a fully remote position focused on clinical safety oversight in medical device studies, particularly for cardiovascular diseases. The ideal candidate will have extensive experience in clinical safety, specifically within the medical device sector, and will play a crucial role in ensuring compliance and high-quality safety data collection.

Salary

Base: $125,000.00 - $201,250.00; Bonus/Equity: Eligible for long-term incentive program; Benefits: Retirement plans, paid time off, parental leave, and other company benefits

Skills & Requirements

Must-have

  • clinical safety management
  • adverse event reporting
  • medical device clinical studies
  • regulatory compliance for clinical studies
  • safety data collection and monitoring
  • vendor oversight and management

Nice-to-have

  • cardiovascular disease experience
  • strong communication skills
  • proficient computer skills
  • team and independent work adaptability
  • knowledge of electronic data capture systems
  • process development and audit participation

Key Requirements

  • RN or equivalent healthcare experience
  • Bachelor’s degree preferred
  • Minimum 10+ years clinical safety experience
  • Experience with medical device clinical studies
  • Expertise with ISO 14155, 21 CFR 812, EU MDR regulations
  • Approximately 10% travel required

Work Rights

Not specified

Tailored Resume

Cover Letter