RA Team leader, Global Registration, BK Medical / 1808
BK Medical is committed to designing ultrasound systems that help surgeons image, guide, intervene, and navigate inside the human body. Surgeons are BK Medicals customers, and they range from HPB surgeons, neurosurgeons, and robotic-assisted surgeons to urologists, colorectal surgeons, and more.
Their mission at BK is to enable real-time intraoperative guidance during surgical procedures, giving surgeons the information needed to immediately make critical decisions. BK Medicals products are designed and customized for surgical procedures, to help surgeons save time and get better results.
As a market leader, BK Medical works closely with experts and universities to provide the best solutions to clinical challenges.
BK Medicals Headquarter are placed in Herlev / Copenhagen in lovely and modern buildings with more than 280 people. The work atmosphere is casual, and the organizational structure is flat. BK Medical have a good staff canteen focusing on health and variety and have private health insurance and pension plans as well as social joint events and several staff clubs.
At BK Medical, they value their employees. Cooperation based upon confidence, straightforward communication and clear objectives results in job satisfaction and good colleagues. BK wish to motivate their employees to take responsibility and influence their own work situation. They value a healthy work environment with compassion for each other in order to obtain good relations and a high job satisfaction.
The Organization and Team
Regulatory Affairs is a part of the RA/QA function belonging to the global organization with offices in Herlev, Denmark and the Global Headquarter in Boston, Massachusetts, US.
The Global Regulatory Affairs Team consists of 13 members: 3 people in US, 1 in China, and 10 people in Denmark. The members of the Regulatory Affairs have a strong regulatory background within Medical Devices and are dedicated to development of safe and effective products for the global customers.
The team is quite diverse and come from many different cultures. They share great respect for each other and are really good at solving challenging tasks together. They value being open minded, professional, trustworthy, honest, and communicating with one voice. They are business oriented and take pride in guiding the organization in the complex regulatory environment. English speaking people are welcome.
Would you like to join BK Medical in a challenging new position as RA Teamleader? They offer an exciting job in an international company with great influence and responsibility. Your contributions will be greatly valued
RA Team leader, Global Registration
You have a balanced focus on both performance & wellbeing
- A market leader with customized products for surgical procedures
- You will be working with regulatory strategies for Medical Devices Class I - III globally
- You are a great leader responsible for a team of 8 dedicated people
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).
They drive global registrations of new innovative products around the globe and ensure, that BK Medical products are timely registered to be provided to their global customers. You will help the team to plan RA strategy, author, and execute documents with the aim of registering products Class I - III globally.
You will be joining RA 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. We are looking for a well-balanced person, who can motivate different types of people and adjust the leader style accordingly and actively drive the following responsibilities
- Managing a team of RA Specialist and Sr RA specialist, globally
- Creating high performance teams and ensure that employees are thriving and familiar with their responsibilities in the team
- Work closely with the Global Regulatory team as well as Product Marketing, R&D and Sales Distribution.
- Lead different projects and ensure project execution on time and to budget.
All these tasks will be carried out in cooperation with the Director for RA and other functions, so you need to thrive by working in a cross functional environment.
BK Medical offers a challenging position within a dedicated company that is characterized by high quality, result orientation and speedy realization of the goals. Since BK Medical experiences rapid growth, there will be good opportunities for personal development and an international career. You will report to the Director of Regulatory Affairs.
You have a degree on Bachelor level in Medical Science, Engineering or equivalent knowledge. You have more than 5 years’ experience in RA in an international Medical Device company. You have been working with Regulatory Strategies during development of new products and have knowledge of CE marking (MDR), FDA 510(K) clearance and product registration. Experience working as a Project Leader will be an asset. You have solid experience in cooperation with relevant national health authorities and Notified Body.
We are looking for a skilled Leader or a person with a well-balanced personality, who want to become a leader. The seniority will be assessed based on your qualifications.
You are a good communicator of ideas, direction and solutions and can navigate in an environment with many stakeholders. The communication will be open, honest, and direct with respect for each other’s skills and expertise. You have talent and passion for leadership, project management and experiences with coordination of complex assignments.
The successful candidate has high quality standards and is committed to meet deadlines. In addition, you are well organized, pro-active, flexible and have the ability to work on multiple tasks. Ability to communicate well verbally and in writing is essential.
In other words, you have a desire to support and enrich BK Medicals culture and would love to work in a leading company with customized products for surgical procedures.
Best Talent is responsible for the recruitment for this position at BK Medical and review your application on a confidential basis. Forward your application including your CV attention “1808/Team Leader” by way of e-mail to firstname.lastname@example.org You can read more about Best Talent at www.besttalent.dk.