Philips Quality and Regulatory Manager / Senior Specialist in Foster City, California
As the incumbent of this Quality & Regulatory (Q&R) role within Philips, your challenge will be to guide and support the Business and enabling functions to always do the right thing . This involves being a confident advisor on global regulatory requirements, 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.
Working in the medical industry brings much fulfillment, as well as unique challenges. As part of the Enterprise Imaging business, you will be responsible for successfully dealing with regulatory agencies such as the US Federal Drug Administration (FDA) and Notified Bodies.
Key areas of responsibilities (KARS) for this role include:
Maintains and enforces a compliant and effective QMS for the activities in scope, as well as for effective and lean QMS structures and Q&R processes.
Manages the transition/ deployment of the Business Group QMS within the Enterprise Imaging QMS.
Support the Director of Q&R to implement the Business’ long-range quality and compliance policy.
Introduces, implements and optimizes quality processes required to ensure product quality and customer satisfaction.
Manages compliance to FDA regulations, international standards and other Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations.
Support regulatory submissions activities. Includes 510ks, Technical Files, and global registrations.
This position is in the Philips Quality Management System (PQMS) capability within the Enterprise Imaging Business. Associated locations and team members you will closely work with are located in Foster City (USA), India, Germany and the Netherlands. It is an additional challenge to work in such a diverse cultural environment – but very exiting at the same time.
We are looking for
A person who is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life for the billions of people our brand touches each year.
Specific skill requirements for this role include:
An experienced quality professional, with a thorough understanding of 21 CFR 820, ISO 13485 and the EU Medical Device Directive.
Experience in interacting with the FDA and Notified Bodies.
US and/or global submissions experience.
The ability to think outside the box to creatively devise compliance solutions with business considerations.
ISO 13485 Auditor (preferred)
Regulatory Affairs Certification (preferred)
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.