Regulatory Affairs Specialist
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Medical Devices organisation, based in Noord-Brabant Netherlands.
o Work according the business applicable processes and as ambassador of the Philips values.
o Participate in and advise cross-functional new product/solution development teams on applicable regulations, requirements, and standards (not in the field)
o Review development quality reports and plans to ensure that the information required for submissions is adequate
o Plan, generate, and coordinate regulatory submissions for product/solution licensing in close cooperation with the regulatory key markets located worldwide.
o Assists with implementation of global regulatory and roadmaps through understanding the competitive market landscape and product marketing strategy
o Advices product design teams on regulatory strategy and requirements for specific new products/solutions
o Support development of the regulatory plan, guidance on risk assessment, and required corrective action to meet regulatory requirements and product registrations.
o Develops and facilitates regulatory submissions, for new product/solutions existing products/solutions.
o Reviews and validates country specific materials like labeling based on the internal procedures.
o Bachelor’s degree in a technical/quality/law discipline
o 1-2 years of experience in the medical device industry
o 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
o Approx. 5% travel annually.
o Preferably familiarity with preparation and submission of 510 (k) , PMA or international
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Vincent van Straten.
The Company
Koninklijke Philips N.V. is a Dutch multinational technology company headquartered in Amsterdam, one of the largest electronics companies in the world, currently focused in the area of healthcare and lighting.Role Description
The Regulatory Affairs Specialist works mostly with countries all over the world on the International registrations. This can be a person that is looking to step into the regulatory field, and wants to learn and work together with some of the brightest experts in the fields of regulatory, quality, development, procurement and manufacturing. With the possibility to learn about regulatory in a medical device industry.Responsibilities
You are responsible foro Work according the business applicable processes and as ambassador of the Philips values.
o Participate in and advise cross-functional new product/solution development teams on applicable regulations, requirements, and standards (not in the field)
o Review development quality reports and plans to ensure that the information required for submissions is adequate
o Plan, generate, and coordinate regulatory submissions for product/solution licensing in close cooperation with the regulatory key markets located worldwide.
o Assists with implementation of global regulatory and roadmaps through understanding the competitive market landscape and product marketing strategy
o Advices product design teams on regulatory strategy and requirements for specific new products/solutions
o Support development of the regulatory plan, guidance on risk assessment, and required corrective action to meet regulatory requirements and product registrations.
o Develops and facilitates regulatory submissions, for new product/solutions existing products/solutions.
o Reviews and validates country specific materials like labeling based on the internal procedures.
Requirements
To succeed in this role, you should have the following skills and experienceo Bachelor’s degree in a technical/quality/law discipline
o 1-2 years of experience in the medical device industry
o 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
o Approx. 5% travel annually.
o Preferably familiarity with preparation and submission of 510 (k) , PMA or international
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Vincent van Straten.
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