Senior Regulatory Specialist (Freelance)
The Senior Regulatory 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.
You are a part of
You will be a team member of the global Philips regulatory organization and will be reporting to the MLD 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.
To succeed in this role, you should have the following skills and experience
- Minimal of 5 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
- 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)
- Bachelor's degree in a technical/quality/law/pharma discipline
- RAPS certified(as a plus)