Senior Regulatory Affairs officer (Freelance)

As a Senior Regulatory Affairs officer in the new business creation hub IGT Innovation, you hold a pivotal position to disrupt Medtech and make a real difference for patients.
We recognize that strategic regulatory thinking is essential in product (architecture and hierarchy) design as well as go-to-market and maintenance strategies for novel disruptive propositions.
IGT Innovation hosts ventures with disruptive products, such as FORS (Fiber Optic-RealShape) and OnVision, spanning the range from single-use sterile in-body devices to complex hardware and software products and solutions.
FORS for example, is a unique technology that enables real-time 3D visualization of the full shape of devices inside the body without the need for fluoroscopy thus allowing us to break through the current limitations of image guided therapy by reducing the dependency on fluoroscopy while vastly improving the visualization of intra-body devices.
Onvision is an innovative needle tip tracking technology for the regional anesthesia. Together with BBraun and Philips Ultrasound a point of care solutions was developed to make regional anesthesia more accessible.

In this customer-centric, fast-learning and agile venture environment we value drive, creativity and solution oriented end-to-end business thinking, and we are looking to hire a Senior Regulatory Affairs officer that will actively engage with Business Management, R&D, Marketing and Clinical as well as Regulatory Affairs colleagues. Here you will establish and operationally execute regulatory strategies, based on a deep understanding of the competitive market landscape, regulatory/legislative initiatives, and the product marketing strategies for the products you are responsible for in IGT-Innovation.

Responsibilities
Developing and implementing global regulatory roadmaps and strategies aimed at optimum regulatory clearance pathways for novel product families.
Providing guidance on global compliance as well as regulatory requirements, such as CE Marking and product registrations, clinical evaluations and ensuring compliance with, including but not limit to EU MDR, ISO 13485, MDSAP and FDA requirements and guidance documents that are relevant to the overall IGT Innovation priorities.
Representing the Regulatory Affairs function in product development and clinical studies:
Establishing global regulatory strategy plans for specific product introductions.
Reviewing applicable plans, reports and records (e.g. R&D, clinical, marketing) and (design) changes to ensure compliance with applicable standards and regulations as well as Philips policies.
Creating and ensuring execution of the Labeling Plans and review and approve product labeling and product-related marketing communications
Planning, coordinating and creating technical files and performing file submissions to regulators (e.g. notified bodies, FDA, competent authorities) to obtain market clearance.
Maintaining existing regulatory files, licenses, certificates and managing updates.
Incidence reportability determination and to ensure timely incidence reporting and follow up with regulatory bodies.
Professionally negotiate directly with regulatory enforcement entities (e.g. governmental agencies, notified bodies, etc.) on regulatory filings at the reviewer level.
Supporting site or QMS certifications and audits.
Ensuring compliance with the current regulatory procedures and where needed, generate new and/or update procedures when new regulatory requirements that are determined to go into effect.
Assigned Person Responsible for Regulatory Compliance for IGT-I products under EU MDR and actors registration in EUDAMED.

You are a part of
Image Guided Therapy, one of the four Philips business clusters, focused on diagnostics and therapy in the cardio-vascular domain, spanning the imaging guidance systems business and the therapy delivery business. Strengthened through recently acquired companies like Volcano, Spectranetics, InTact Vascular and EPD Solutions.
The overall strategy of IGT is to create an integrated clinical solution business that supports customers throughout the entire minimally invasive procedure and beyond.
The entrepreneurial, multidisciplinary IGT Innovation venture teams acts as a start-up in the large corporation. Its main goal is to build new businesses and acquire new skills whilst leveraging the competencies of the broader Philips organization.
You will report to the FORS Venture Manager and are functionally connected to the IGT Regulatory Affairs community.
The IGTI ventures are based in Best (Netherlands) and operate globally.

To succeed in this role, you should have the following skills and experience
BS degree in a relevant field. MS or PhD in engineering or science field preferred
8~ years of medical device experience, and 5~ years work experience in regulatory affairs.
First line experience with US FDA and Notified bodies is required.
Maintains detailed knowledge about ISO 13485 and QSR requirements and working knowledge of medical device regulations, such as 21 CFR, FDA law and EU MDD/MDR.
Must have experience surrounding international regulatory submissions and registrations in the relevant geographies (such as clinical trials, UDI, NOTIS etc.)
Must have hands-on experience with successful preparation and submission of Technical Documentation such as 510(k), De Novo, PMA, and registrations of medical devices globally.
Able to identify risks within regulatory strategies, project plan, and outline proposal for balancing the project risks to projects teams and RA management.
Experience with Minimally Invasive (vascular) Devices, Medical Electrical Devices, Software as a Medical Device is preferred.
Self-propelling team player who can work in an environment with teams in various locations.