Regulatory Affairs Specialist
• The Regulatory Affairs Specialist works mostly with countries all over the world on the International registrations and support in special actions like CAPAs. This can be a person that has minimal knowledge in RA but is looking to get a better understanding how Regulatory works in the international market(outside of EU, USA, Canada and Japan).
o Work according the business applicable processes and as ambassador of the Philips values.
o Works with the RA project Leads to get the required information to get clearances for the products that are changed or released towards the markets.
o Takes lead for RA CAPAs and support the International team RA manager to close CAPAs
o Support development of the regulatory plan, guidance on risk assessment, and required corrective action to meet regulatory requirements and product registrations such as , but not limited to , CE marking and clinical evaluations.
o Develops and facilitates regulatory submissions, for new product/solutions existing products/solutions in the international markets.
o Reviews and validates marketing and labeling materials based on the internal procedures.
You will be a team member of the global Philips regulatory organization and will be reporting to the Director of Regulatory for Image Guided Therapy systems (IGT-S). Our team: the team you will be working in is a high-performance, culturally diverse, and very dynamic. It consists of 21 people working in the areas, divided over India and the Netherlands.
o Bachelor’s degree in a technical/quality/law discipline
o 1-2 years of experience in the medical device industry
o Familiarity with preparation and submission of 510 (k) , PMA or international documents or registration and marketing of medical devices worldwide
o Working knowledge of medical device regulations (21CFR), FDA Law, MDD, other global laws and regulations.
o Some experience in supporting international registrations and clinical investigations