Senior Innovation Regulatory Affairs Specialist
In this role, you have the opportunity to
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 are responsible for
- 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
You are a part of
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.
To succeed in this role, you should have the following skills and experience
- 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 (required)
- Experience with the global registration of standalone software in medical devices and the positioning of software in combination with other medical devices (required).
- 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
In return, we offer you
We welcome you to a challenging, innovative environment with great opportunities for you to explore.
Our benefits are very competitive and designed around your preferences:
- A market conform salary
- 25 Days of leave + 5 Personal development/care days and the possibility to purchase up to 20 extra days off annually
- A variable bonus based on both Philips results and personal performance
- Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
- Solid company pension scheme and attractive collective health insurance package
- Opportunity to buy Philips shares and products with discount
- Healthy work-life balance
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
Er is geen minimale opleiding vereist
Wat wij bieden