In this role as Principal Regulatory Affairs Specialist you will become part of a dynamic environment where latest technologies like augmented reality, artificial intelligence, cloud computing and robotics are used to create clinical and/or economical value in the field of diagnostic and interventional imaging. In the Innovation group of Philips Image Guided Therapy – Systems (IGT‑S) we are working on exciting new solutions to better serve the needs of patients and physicians while lowering the cost of care. The group consists of clinical, technical and business professionals which, together with their network, work in an agile fashion on clinical studies, clinical prototypes or even on small scale product introductions as part of a venture team. Take on the challenge of the associated regulatory environment where regulatory pathways are still to be explored and cannot solely be based on the concept of predicate devices!
You will be a member of the IGT‑S regulatory team which is part of the global Philips Regulatory organization and will be reporting to the Director of Regulatory for IGT‑S.
The IGT‑S RA team is a high‑performance, culturally diverse, and very dynamic team. It consists of 40 people located in India, China and the Netherlands. This position is located in the Netherlands and supporting the needs of the IGT‑S innovation group.
Your role:- Developing and implementing regulatory strategy to support the innovation and new business development roadmap.
- Coordinating and preparing (pre)submissions and participating in meetings with FDA and other external regulatory agencies
- Creating the content of (pre)submission packages for investigational devices and product releases
- Planning, coordination and preparation of document packages for regulatory submissions to all targeted countries
- Creating an environment of positive feedback, and use professional concepts and company objectives to resolve complex issues in creative and effective ways.
- Supporting clinical scientists and analysts in setting up partnerships, studies and supporting investigations initiated by clinicians in the field, ensuring compliance with regulatory standards
- Master of Science or PhD in a technical or clinical domain
- Minimum of 10 years relevant working experience in medical device or pharma related to regulatory strategy development supporting submissions and product market introductions (required)
- Experienced in leading regulatory affairs projects to create/ensure required CONTENT of documentation intended for regulatory submissions (required)
- Excellent working knowledge of medical device regulations, FDA law, and regulations (requirement)
- Extensive RA related experience of software medical devices/pharma on cloud/IT platform would be highly preferred
- Experience with the global registration of standalone software in medical devices and the positioning of software in combination with other medical devices would be highly preferred.
- Experience with the medical practice of diagnostic and/or interventional imaging and thereby able to quickly capture the essential aspects and risk profile of our (investigational) devices
- Entrepreneurial and creative mindset
- Excellent verbal and written communication skills (English)
- Good communicator and team player who is able to work in a flexible and goal-oriented environment.
- Approx. 5% travel annually
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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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#J-18808-Ljbffr€85000 - €120000 monthly