Regulatory Affairs Specialist

1 week ago


Nashville, Tennessee, United States Philips Full time

About the Role:

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Philips. As a key member of our regulatory team, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.

Key Responsibilities:

  • Develop and implement regulatory strategies for worldwide regulatory approval
  • Prepare and submit regulatory documents to the FDA, EU, and other government agencies
  • Coordinate the planning, preparation, and publication of regulatory submissions
  • Negotiate and interact with regulatory authorities to ensure timely submission approval
  • Anticipate and mitigate regulatory obstacles and emerging issues throughout the product lifecycle
  • Maintain regulatory documentation to support compliance with regulatory requirements
  • Participate in internal and external quality system audits

Requirements:

  • 5+ years of experience in medical device regulatory or quality assurance field
  • Knowledge of quality system requirements and FDA and/or International product approval process
  • Demonstrated track record in obtaining FDA clearances and/or worldwide registrations
  • Bachelor's degree in life sciences or a related field

About Philips:

We are a health technology company dedicated to improving the lives of patients and healthcare professionals around the world. Our purpose is to make a meaningful difference in the lives of others, and we are committed to creating a better and fairer future for all.

What We Offer:

  • A competitive salary range of $77,000 to $136,000 annually
  • A comprehensive benefits package, including PTO, 401k, HSA, stock purchase plan, education reimbursement, and more

Philips is an Equal Opportunity Employer:

We are committed to diversity and inclusion in the workplace. We welcome applications from qualified candidates who share our values and are passionate about making a difference in the lives of others.



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