Principal Regulatory Affairs Specialist

Philips UK

Murrysville, PA, US
Base: $122,000 to $217,000; bonus/equity: annual i...
Fully remote
New product development oversight
Regulatory compliance standards
Negotiate with regulatory enforcement
Lead and provide regulatory oversight for critical new product development projects, ensuring state-of-the-art Ultrasound Products meet regulatory compliance standards

Job Summary

  • Lead and provide regulatory oversight for critical new product development projects, ensuring state-of-the-art Ultrasound Products meet regulatory compliance standards.
  • Identify risks within regulatory strategies and project plans, outlining proposals for balancing project risks.
  • Provide regulatory support for (pre-) clinical studies, including recommending strategies to optimize clinical study approvals.

Matching Summary

Lead and provide regulatory oversight for critical new product development projects, ensuring state-of-the-art Ultrasound Products meet regulatory compliance standards.

Salary

Base: $122,000 to $217,000; Bonus/Equity: Annual incentive bonus, sales commission or long-term incentives may be offered; Benefits: Generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement

Skills & Requirements

Must-have

  • New product development oversight
  • Regulatory compliance standards
  • Negotiate with regulatory enforcement
  • Quality Management System improvement
  • Clinical study support
  • Global regulatory compliance procedures

Nice-to-have

  • Work in a matrixed organization
  • Collaborate with global teams
  • Mentor and coach professionals

Key Requirements

  • 8+ years Regulatory Affairs experience
  • Bachelor’s Degree required
  • US work authorization required

Work Rights

US work authorization required

Tailored Resume

Cover Letter