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Over de functie
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
• 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.
• Specialist in MDR regulations only.
We offer the opportunity to play a leading role in achieving Philips's ambitions with digitally connected products and to truly contribute to the way our innovations improve the health and well-being of our customers. You will work in close cooperation with colleagues from the Electronics department as well as other Software departments across Philips, playing a key role in driving the transition process that will turn Philips into a Digital Systems company. We invite you to be part of a challenging, innovative environment with great opportunities for personal development.
Philips is one of the largest electronics companies in the world, currently focused in the area of healthcare. It strives to make the world healthier and more sustainable through innovation, The company's goal is to improve the lives of 3 billion people every year by 2025. They aim to provide the best possible workplace for people who share their passion.
Philips is a diversified technology company and a market leader in the fields of cardiac care, acute care home healthcare, energy-efficient lighting solutions, and new lighting applications, as well as shaving, grooming, and oral care products.
Voor meer informatie neem je contact op met Apurva Inglekar via telefoonnummer 06-51041905
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