Senior Specialist -RA

Job Description

Job Title Senior Specialist -RA Job Description Job title: Senior Specialist -RA Job Description You are a part of Global Philips regulatory organization and will be reporting to the India (Bangalore) Regulatory leader for Image Guided Therapy Systems (IGT-S). The team you will be working in, is a high-performance, culturally diverse, and very dynamic team. It consists of 35 people working in the areas, divided over India and the Netherlands. The Specialist provides strategic input during product creation process and supports in developing the department s overall regulatory strategy plan. At IGT-S the Senior Regulatory Specialist cooperates closely with Product Development, Medical / Clinical Affairs and Marketing and Sales. We are looking for a regulatory affairs expert that has experience with submission of medical devices(FDA, Health Canada, EU, etc.) and is looking for a challenge in coaching her/his RA project team members next to leading in the difference regulatory affair activities like new project introductions, maintenance projects and process improvements. You are responsible for Work according the business applicable processes and as ambassador of the Philips values. Train regulatory resources in their development. Exercise supervision in terms of schedules, methods and staffing for projects leading Establishes operational objectives and work plans, and delegates assignments to project team members. Keeps abreast of current regulatory procedures and changes Key role in external and internal audits related to product submission such as FDA, MFDS, NMPA etc. and notified body audits.(support)Reviews and recommends changes for labeling, and clinical protocols to maintain regulatory compliance. Responsible for developing and implementing global regulatory and roadmaps though deep understanding of the competitive market landscape , regulatory/ legislative initiatives, and product marketing strategy for their responsible products within IGT-S Fixed portfolio Responsible for product registrations/approvals in her/his field. Leads regulatory resources as part of projects (s)he works in To succeed in this role, you should have the following skills and experience Minimal of 8-10 years of experience in the medical device industry and technical environment with at least 3 years in an Imaging Diagnostic medical device company( FDA Class II equivalent - Class III a plus) Must have experience with successful preparation and submission of 510 (k) , PMA or international documents or registration and marketing of medical devices worldwide Strong background in Design Controls Strong knowledge in SaMD & System Excellent working knowledge of Standards like IEC62304/82304/60601 Excellent working knowledge of medical device regulations (21CFR), FDA Law, MDD, MDR, other global laws and regulations. Experience in supporting international registrations and clinical investigations(as a plus) Approx. 5% travel annually with some international. Bachelor s degree in a technical/quality/law/pharma discipline RAPS certified(as a plus) How we work at Philips Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart - which for full-time employees translates to 3 days working from the office and up to 2 days from home - for our hybrid roles. Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way. Our commitment to inclusion and diversity Our hybrid working model is defined in 3 ways: We believe in the importance of impactful collaboration: Theres a certain energy when everyone s in the same room that can heighten idea generation and creative friction needed for problem-solving. We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis. We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best. Why should you join Philips? #LI