As a Quality and Regulatory Compliance Reviewer you will be guiding and supporting the Process Owners in our Personal Health business segment, ensuring a Quality & Regulatory 4-eye principle of Quality Management System content and maintaining Regulatory standard and regulation traceability matrices, you play a vital role in ensuring and maintaining compliant Personal Health Quality Management Systems.

　　Your role:

　　Provide guidance, support and interpretation of Quality and Regulatory compliance requirements, to Personal Health Process Owners during their process design efforts.

　　Ensures adherence of Quality and Regulatory requirements in Quality Management System processes, developed by Personal Health Process Owners, by reviewing and approving Quality Management System content as Q&R Compliance Reviewer.

　　Identify and signal any gaps in the traceability matrices with Personal Health relevant Regulatory Standards and Regulations to the Personal Health Process Owners and/or Personal Health Process and Systems Excellence team.

　　Support external regulatory assessments and internal audits by providing Regulatory Standards and Regulation traceability matrices and subject matter expertise.

　　Increase awareness and understanding in the organization of the Regulatory Landscape applicable to Personal Health Quality Management Systems.

　　Maintain communication with Philips central Q&R and non-Q&R compliance domain owners and act as the Personal Health representative for co-creation and improvements of the Q&R and non-Q&R Compliance Requirements tool.

　　You're the right fit if:

　　At least a Bachelor’s degree in an engineering or scientific-related field or other plus equivalent technical experience working in a consumer business and/or medical device environment

　　5+ years’ practical experience with regulations and standards for medical and non-medical consumer products, pharmaceutical and/or cosmetics

　　Strong understanding of appropriate global regulations, requirements, and standards such as FDA 21CFR Part 820/Part 11, ISO 13485, EU MDR, EU Annex 11 and ISO 9001

　　Preferred knowledge of ANVISA, CDMR, TGA, MFDS, MHLW, CFDA, TFDA and ISO 14971 requirements

　　Able to understand and analyze complex problems

　　Demonstrated ability to partner with the business and effectively interact with and influence employees, process owners and managers on all levels

　　Strong planning, communication, presentation skills, people management and leadership qualities

　　Strong Project Management skills, including ability to project manage QMS compliance improvement activities

　　Strong reasoning and logical thinking skills

　　Excellent written and verbal communication skills in English

　　About Philips

　　We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.

　　Learn more about our business.

　　Discover our rich and exciting history.

　　Learn more about our purpose.

　　If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

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