In this role, you have the opportunity to:
Guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being 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.
You are responsible for:
Successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA).
Primarily responsible for assisting organizational units in addressing compliance deficiencies.
Ensuring external audit readiness and providing support during external audits
Identifying and sharing best practices within Philips
Delivering training on key compliance topics
Performing timely, detailed, and independent internal Quality Management System (QMS) and/or Good Clinical Practice (GCP) audits to assess regulatory compliance to applicable local and international regulations/standards and Philips requirements
Reviewing responses to audit findings for completeness and effectiveness
Participating in Quality & Regulatory initiatives as a cross functional contributor
You are a part of:
As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit.
To succeed in this role, you should have the following skills and experience:
Bachelor’s degree. plus a minimum of 10 years of related experience in the medical device or another regulated industry
Certified Lead Auditor; or ASQ certification as a Certified Quality Auditor (CQA) and/or Certified Biomedical Auditor (CBA); or Certification with a recognized Accreditation body (i.e. RAB-QSA / IRCA)
Expert understanding of appropriate global medical device regulations, requirements and standards, including FDA’s 21 CFR Parts 50, 54, 56, 803, 806, and 812, 820, ISO 13485, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, ANVISA, ISO 14971, ISO 9001, ISO 14155, and ICH E6.
Government/regulatory-body Quality System auditing/inspection experience preferred (i.e., former FDA)
Legal and/or scientific background preferable
Demonstrates considerable knowledge of, and success with performing on, compliance-related projects, including:
Development and assessing compliance programs, constructing, monitoring and auditing programs, managing internal risk assessments and/or investigations, implementing compliance solutions;
Common issues facing the Healthcare industry, as well as industry best practices;
Project Management (development of project plans, status meetings, project reporting, etc.) and organizational change management;
Communication in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor
Attention to detail
Solid organizational and interpersonal skills
Ability to analyze information and come to conclusions based on presented data
Ability to communicate effectively both orally and in writing
Manage time working on multiple projects simultaneously
Open to other’s ideas and working collaboratively across functions and/or businesses
Ability to travel 75% of the time with possibly some international
In return we offer you:
This role comes with a competitive compensation offering and a generous holiday / vacation offering, but that’s not all. Quality is right on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, ground breaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role’s mission, you will have an array of diverse career options open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.
Find our more information about Philips at www.philips.com/na/careers
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.