RA Operations Specialist

RA Operations Specialist

In this role, you have the opportunity to
be responsible for bringing products to the market, and prepare of regulatory document packages for regulatory submissions (Global, FDA, EU, Asia, etc.). The RA Operations Specialist also provides input during product creation process.

At Philips Digital & Computational Pathology, the RA Operations Specialist cooperates closely with Product Development, Medical / Clinical Affairs and Marketing and Sales.

You are responsible for
•   Reviewing and creating the content of the global submissions: Assuring regulatory compliance throughout the full life cycle of the device, including defect and complaint reviews for product life cycle teams, provides guidance to the team on risk assessment and required actions to create objective evidence that meets regulatory requirements
•   Planning, coordination and preparation of document packages for regulatory submissions to the US, EU, China, Asia [e.g. 510(k) Pre-market Notifications, Product Reports/Supplements, CE Marking, EU IVD, Health Canada]
•   Creating an environment of positive feedback, and use professional concepts and company objectives to resolve complex issues in creative and effective ways

You are a part of
a global business that leads the change to digital and computational pathology. Philips IntelliSite Pathology Solution has an in vitro diagnostic device status in more than 50 countries e.g. in Europe, USA, Middle East and Asia. Philips IntelliSite Pathology Solution is the first digital pathology solution available for primary diagnosis in the United States of America and Japan. With a full portfolio of solutions for computational pathology, education, research and collaboration, Philips supports the transformational change of digital pathology to empower decision-making and precision diagnostics.

To succeed in this role, you should have the following skills and experience

Must have:
•   Bachelors or Master in a technical field
•   Minimum of 7 years relevant working experience in (IVD) medical device related to regulatory strategy development supporting submissions and product market introductions
•   Experienced in leading regulatory affairs projects to create/ensure required content of documentation intended for regulatory submissions
•   Excellent working knowledge of global (IVD) medical device regulations
•   Excellent verbal and written communication skills
•   Good communicator and team player who is able to work in a flexible and goal oriented environment

Nice to have:
•   Ideally regulatory affairs related experience of software medical devices on cloud/IT platform
•   Experience with the global registration of standalone software in medical devices and the positioning of software in combination with other medical devices.

Not suitable:
•   Specialist in MDR regulations only.