Do you dream of a job where you are part of a great team, and at the same time open for an exciting international career opportunity for yourself? You will be part of a group that ensures BK Medical products are timely registered to be provided to their global customers. You will plan regulatory label strategy and execute and review documents with the aim of registering products Class I - III globally.
You have a passion for medical device development and are motivated by understanding the user-situation and the user-needs. You have a drive to secures a high-quality user experience. The job includes execution and support to device development, device manufacturing and lifecycle management improvement projects for drug delivery devices.
Your role will specifically focus on QA oversight of outsourced analytical testing for starting materials, intermediates, Drug Substance and Drug Product. You will support and conduct review- and approval of i.e., analytical documentation, quality system records such as deviations, change controls and CAPAs and other operational related documentation. Moreover, you contribute actively to the department relevant projects such as continuous upgrades of quality systems SOPs, support launch activities, execution of regular quality management reviews, IT projects etc. Finally, you work to ensure continuous good relations and alignment with CMOs worldwide and stay updated with insights into their methods and processes.
As Associated Director you will be responsible for a team of engineers and scientists working in a cross-field between device development and life cycle management as well as production transfer and technical support to the production site. You will be joining colleagues that are highly skilled and have vast experience in their field of expertise and there for you have focus on leadership, setting clear directions, prioritizing, manage resources and the team’s performance & well-being
Do you want to lead a team of 8 dedicated people to secure safe and effective new products within intraoperative ultrasound imaging around the globe? It is a new challenging position in a rapidly increasing organization, and we are looking for a RA Team leader with drive and energy to join the Global Registration Team. The team is situated in Denmark (Herlev), USA (Boston) and in China (Shanghai).
As Director, QA Commercial Drug Substance, you will lead a team responsible for the oversight of drug substance manufacturing at our CMOs (Contract Manufacturing Organizations). You will become a part of a dynamic and competent department, contributing to the development of the QA Commercial organization and get the opportunity to contribute with your knowledge and experience.
Can you think strategically, create coherence cross the sectors and secure the continued favourable development in new and existing investment areas? The Business Unit has great growth potential, and you can become the next valuable member of the Management Team. As the new Business Unit Manager, you will lead the development of the Life Science business with both existing and new customer relationships in the Öresund Region.
Can you think strategically, create coherence cross border, and secure the continued favourable development in new and existing markets? The European market has great growth potential, and you will be given the responsibility to develop both the direct sales and a new distribution network in Europe. You will also have direct influence and responsibility on developing a German organisation. As the new Sales Manager Europe, you will lead the development of the business both within existing and new customer relationships.