Quality and Regulatory Specialist

Job TitleQuality and Regulatory Specialist

Job Description

Your Challenge:

As a Quality and Regulatory Affairs Specialist, we challenge you to be a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.

Your Responsibilities:

  • As a core member on the Philips Burton Customer Service team, the Regulatory Specialist will provide timely and valued regulatory guidance (written and / or verbal) by owning the following tasks:
  • Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.
  • Create detailed written regulatory plans that can be used to target domestic and international shipment dates.
  • Develop and prepare product registration submissions for the US.
  • Review and approve engineering changes, advertising, promotional items and labeling (UDI) for regulatory compliance.
  • Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
  • Provide significant regulatory support to ongoing PMA activities.
  • Communicate application progress to internal stakeholders
  • Collaborate with worldwide colleagues regarding license renewals and updates
  • Maintain regulatory files and tracking databases as required
  • Communicate with regulatory agencies as needed

Your Team:

Philips Burton is a medical device manufacturer engaged in the business of designing, manufacturing and distributing high-quality examination, and surgery lighting equipment. Since its inception in 1928, Burton has been known for superior quality, exceptional value, and long-lasting solutions to complex lighting issues facing physicians, surgeons and veterinarians throughout the world. Philips Burton has over 250,000 lights installed in the United States alone and continues to grow based on its quality, reliability, and extraordinary five-year warranty. Philips Burton is part of Royal Philips and is located in Franklin Park, Illinois, just west of Chicago.

We are looking for:

A person who is excited by the unique professional challenges, who has strong technical competencies, and demonstrates resilience challenging, often demanding situations. We're looking for someone who can inspire others to adopt a "quality mentality" of prioritizing quality above all else in a relentless pursuit to improve the quality of life billions for the billions of people Philips brand touches each year.

  • Bachelor's degree preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry.
  • RAPs RAC strongly preferred. ASQ certifications also desirable.
  • Minimum of 3 years of experience in the medical device industry (US FDA class I and class II etc.).
  • Knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws and regulations and standards.
  • Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision
  • Proficient knowledge of domestic and international standards
  • Strong background in Design Controls.
  • Experience in supporting international registrations and/or clinical investigations are a plus.
  • Must be able to manage multiple tasks and perform with accuracy and a high attention to detail
  • Proficient computer skills in Microsoft Office.
  • Understand LEAN concepts, methodologies and deployment.
  • May require 5% travel annually

Advance your career in an environment that supports work-life balance, well-being and continuous learning. Making an impact through meaningful innovation starts here. Apply today!

Visit our careers website to learn more about Philips Lighting or introduce yourself on our Talent Community.

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.

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