Regulatory Affairs Specialist
Posted on Jan 30, 2020 by Randstad Multilingual Recruitment Banen
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 pan, 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
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€50 - €60 Annual