EMEA QA/RA Director
Location: NetherlandsSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science 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!
THE COMPANY
Our client is a professional Medical Devices organization, based in Noord-Holland Netherlands.
They are an international company with industry leading medical devices on many different specialisations. You will join the company at a point where it is grown all over the world that enables opportunities for all. They are looking for someone who is well experienced within the QA/RA international medical device industry but is not satisfied easily and still wants to make an impact on the world
ROLE DESCRIPTION
As EMEA Director of Quality Assurance and Regulatory Affairs it is your task to direct and oversee all regional RA, QA and GA (governmental affairs) for the company within the EMEA region. You will as well be single point of contact with the parts of the world regarding all regulations such as FDA QSR, ISO 13485, MDD, Canadian MD requirements and Japan’s pharmaceutical Affairs Law. You provide guidance and recommendations to other departments and other regions. This means that you will determine the strategy for EMEA as well as other regions and lead the company towards a stronger position in the market.
RESPONSIBILITIES
As being responsible for EMEA you will ensure that the EMEA organisation is bound with its strategy conform the companies long term goals and RA, QA and GA are well executed.
• Determine priorities and design strategies to support EMEA business
• Assess the opportunities and implement them into the strategies to ensure a proactive approach towards the market and all necessary agencies/regulatory bodies
• Coordinate RA/QA activities in future plants and manufacturing sites and develop strategies
• Serve as a single point of contact between the company and all necessary governments/agencies/regulatory bodies
• Manage and supervise different QA/RA teams through the EMEA region as they will carry out and support all related tasks necessary
REQUIREMENTS
• At least a bachelor of science in a life sciences related field
• A minimum of 13 years experience in Medical Device industry with 10 years in Quality Assurance or Regulatory Affairs
• Proven work knowledge of at least 5 years in Governmental Affairs
• Managing experience of at least 5 years
• Excellent communication skills and being able to communicate on different levels within a company or externally towards other organisations
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Jeroen Evertsen.
