Medical Device Quality Management Expert

1 week ago


Colorado Springs, Colorado, United States Philips Full time

**Overview of the Role**

We are seeking a talented Regulatory Compliance Specialist to join our team at Philips. In this role, you will be responsible for managing compliance with FDA regulations and other regulatory agencies as required, ensuring that guidelines and policies are consistent with those regulations.

Your primary responsibilities will include:

  • Ensuring that quality systems and processes are aligned with regulatory requirements.
  • Developing and implementing corrective action plans to address any non-compliance issues.
  • Coordinating efforts with cross-functional teams to ensure completion of regulatory-related tasks.
  • Providing training and guidance to colleagues on regulatory matters.

About Philips

We are a leading health technology company dedicated to improving lives through innovative healthcare solutions. Our mission is to make a meaningful difference in people's lives by providing cutting-edge technologies and services that address some of the world's most pressing healthcare challenges.

Compensation and Benefits

The salary range for this position in Colorado Springs, CO is $90,000 to $150,000 per year. In addition to a competitive salary, we offer a comprehensive benefits package, including a generous PTO plan, 401(k) matching, HSA contributions, stock purchase plan, education reimbursement, and more.

Qualifications**

To be successful in this role, you will need to have:

  • A Bachelor of Science degree or equivalent years of experience managing and maintaining quality management systems in a highly regulated environment.
  • 4+ years of experience in medical device or highly regulated industry focusing on quality functions, maintenance, and/or improvements of quality management systems and supporting regulatory audits/inspections.
  • Experience with Class III medical devices/combination devices and basic understanding of global medical regulations, requirements, and standards.
  • Excellent communication skills, both written and verbal, and the ability to present to management teams.


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