Quality & Safety
Secondment via YER
Medical & Health
About this vacancy
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.
- 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 labelling, 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.
With a growing presence in cardiology, oncology, and women's health, Philips operates in the areas of Imaging Systems, Patient Care & Clinical Informatics, Home Healthcare and Customer Services. Philips combines its clinical expertise and human insights to create innovative solutions across the continuum of care, in partnership with clinicians and our customers, to provide better value and expand access to care for millions. Our teams are working hard every day to improve patient outcomes all the way from disease prevention and screening to diagnosis, treatment, therapy monitoring, and disease management. Irrespective of whether the care cycle takes the patient from doctor's office to hospital or hospital to home, or simply from one medical department to another, Philips Healthcare's unique medical solutions are designed to optimize the quality and flow of patient information and clinical decision-making.
You will be employed by YER and seconded to Philips. We offer:
- Good employee benefits (e.g. work-life balance, pension, lease car, bonus model);
- Challenging assignments;
- Excellent guidance from your consultant and YER's back office;
- Development opportunities, including the YER Talent Development Program with a personal coach;
- Intensive support for international candidates (including Dutch lessons, tax-return and accommodation assistance);
- Cooperative and results and relationship-driven;
- Friendly atmosphere and open culture;
- Community/network with other technology professionals from a variety of multinationals;
- Events and master classes with interesting speakers and attractive companies.
- Minimum 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