Senior Regulatory Affairs Manager
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.
+ Involved early in Advanced Development Projects and Value Proposition Creation
+ Create Assessments of Medical Device Classifications for applicable Markets globally
+ Create Regulatory Strategy Plan for new device projects
+ Global medical device regulation knowledge for EU (MDD and EU-MDR), United States (FDA), Brazil (Anvisa)
+ Proven successful track record in regulatory submissions for medical devices
+ Familiar with MDSAP and ISO 13485
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Suleyman Ekiz.
The Company
One of the largest Medical Devices companies in the world.Role Description
In this position the Sr. Manager will responsible for leading High Profile Medical Device development projects for the Beauty business who is part of Personal Care.Responsibilities
+ Take “Regulatory Ownership” of the Medical Devices, being the primary point of contact for the development teams.+ Involved early in Advanced Development Projects and Value Proposition Creation
+ Create Assessments of Medical Device Classifications for applicable Markets globally
+ Create Regulatory Strategy Plan for new device projects
Requirements
+ (10+ year) experience in medical device regulations, in a commercial environment+ Global medical device regulation knowledge for EU (MDD and EU-MDR), United States (FDA), Brazil (Anvisa)
+ Proven successful track record in regulatory submissions for medical devices
+ Familiar with MDSAP and ISO 13485
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Suleyman Ekiz.
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