Senior Regulatory Affairs (RA) Manager
Posted on Jan 31, 2020 by Randstad Multilingual Recruitment Banen
The Senior RA Manager is a combination of People and Regulatory roadmap management.
You manage your project RA experts and represent RA in the Project Management team.
There you provide strategic input during product creation process and support in developing the department s overall regulatory strategy. At Philips Image Guided Therapy Systems (IGT S) the Senior RA Manager cooperates closely with Product Development, Medical Clinical Affairs and Marketing and Sales. We are looking for a regulatory affairs expert that has experience of medical device submissions (FDA, Health Canada, EU, etc.) and is looking for a challenge in managing her his project RA experts and leading the Roadmap challenges in the different regulatory affair activities such as new project introductions, maintenance projects and process improvements. This role may lead steady job if there is a right candidate.
Your responsibilities are to
o Work according to the business applicable processes and as ambassador of the Philips values.
o Manage, mentor and coach regulatory resources in their development.
o Exercise supervision in terms of budgets, schedules, methods and staffing
o Establish operational objectives and work plans, and delegate assignments to subordinates.
o Keep abreast of current regulatory procedures and changes
o Take a key role in (external) audits related to product submission such as FDA, MFDS, notified body etc.
o (Support)review and recommend changes for labeling, and clinical protocols to maintain regulatory compliance.
o Develop and implement global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory legislative initiatives, and product marketing strategy for the products within IGT S Fixed portfolio
o Undertake and manager product registrations approvals in your field.
o Lead regulatory resources as part of projects you manage.
You will be
team member of the global Philips regulatory organization and will be reporting to the Director of Regulatory for IGT S. Our team the team you will be working in is a high performance, culturally diverse, and very dynamic one. It consists of 20 regulatory experts divided over India and the Netherlands.
To succeed in this role, you should have the following skills and experience
o Minimum of 6 9 years of experience in the medical device industry and technical environment with at least 5 years in an Imaging Diagnostic medical device company( FDA Class II equivalent Class III an advantage)
o Minimum of 2 years of people management experience is required Experience managing distributed, multi national teams is preferred
o Excellent working knowledge of medical device regulations (21CFR), FDA Law, MDD, MDR, other global laws and regulations.
o Minimum of a B.A B.Sc. is required
o RAPS certified(preferred)