MDR Program Director

Send your application in English to:
[email protected]
Mark the application:
“MDR Program Director”
We conduct interviews as we receive
applications
MDR Program Director
Are you passionate about MDR and leading project organizations?
Join us to provide intraoperative ultrasound solutions to Global
Health Care Providers.
MDR Program Director
You:
Do you have a passion for leading Medical Device project
• Certified Project Leader
organizations to bring Intraoperative Ultrasound solutions to global
• Well acquainted with Medical Device Regulation.
patients?
• Have more than 5 years experience in Program management
We have an exciting position that can be the starting point in an from an international medical device company.
international career with BK Medical that are now part of General
• University degree on bachelor level within science, engineering
or equivalent
Electric.
• Ability to communicate well verbally and in writing is essential,
We are looking for an experienced Program Director with a proven
as well as fostering resolutions to complex issues and
coordinate among different functional areas is key
track record for encouraging the cross functional team to complete
• Fluent in oral and written in English
Medical Device development projects according to plan.
In this new position you will work closely with MDR Program Owner
At our European headquarters in Herlev the work atmosphere is
and Steering Committee team as well as project members from R&D,
casual, and our organizational structure is flat. We have a good staff
canteen focusing on health and variety, we have private health
RA, QA, Product Marketing and Operations.
insurance and pension plans as well as social joint events and several
We are looking for a new team member with a positive and proactive staff clubs.
mindset. You thrive in an international environment with a high pace.
You enjoy being part of a committed team and take pride in finalizing
the tasks together with the team. If these challenges are interesting for you, please send your
application to:
In this position you will lead the MDR Program activities with an [email protected]
organization of +40 FTE, drive project plans and execution as well as
being responsible for Steering Committee meetings and budget. Mark the application:
“MDR Program Director”
The position is temporary for 2 years.
We conduct interviews as we receive applications.
Global RA and QA
The RA/QA function is a global organization based in the European
Headquarters in Herlev, Denmark. We have colleagues in Boston and
State College in US as well as Shanghai in China. The function globally
consist of 38 colleagues.
The Global RA/QA team is an organization committed to our patients, our
customers and operational excellence that puts patient safety first.
Together we drive the strategic direction of regulatory affairs, policy,
clinical and medical matters, ensuring regulatory requirements are met
and products are introduced to markets around the world efficiently and
effectively. Our team is dedicated making quality our competitive
advantage for all our products and services in every country around the
world.
We work closely with global key stakeholders in R&D, Product
Management, Operations, Customer Service, Clinical Marketing and
Sales to deliver high quality product solutions to Health Care Provides.
Susanne Holm Faarbæk
Sr Director Global RA/QA
+ 45 31 62 51 29
BK Products Guides Procedures for the Surgeon
Urologist Neurosurgeon HPB Surgeon
Colorectal Surgeon Robotic Surgeon Adjacent Market Users
BK Medical
“By working within these
Global Organization
specialties, I realized that I could
BK Medical is an international company with sales offices all over the world, and European headquarters in
provide or improve the health care
Herlev, Copenhagen.
system that way.”
At BK Medical, we support employees in developing their skills and expertise. We have a professional and
informal organization with flexible working conditions and a flat organizational structure. We are effective
- Rikke von Barm, Specification Engineer
and can execute our ideas into strong products – these ingredients make BK Medical an exciting and
development-oriented workplace.
We look forward to welcoming you to a team that makes a difference – a difference to quality of life.
Intraoperative Ultrasound
BK Medical is committed to designing ultrasound systems that help surgeons image, guide, intervene, and
navigate inside the human body. Surgeons are our customers, and they range from HPB surgeons,
neurosurgeons, and robotic-assisted surgeons to urologists, colorectal surgeons, and more.
Our mission at BK is to enable real-time intraoperative guidance during surgical procedures, giving
surgeons the information needed to immediately make critical decisions. Our products are designed and
customized for surgical procedures to help surgeons save time and get results.
Now, BK Medical is advancing its mission with GE Healthcare. Together, we will reach more customers and
continue to empower surgeons to make critical decisions that allow for better care, faster procedures, and
reduced complications.
As market leaders, we work closely with experts and universities to provide the best solutions to clinical
“I chose to pursue a career in the
challenges.
medtech industry because I want
Research and Development
to work at a place where both the
BK Medical has development departments in Denmark and the US. The largest development team is based
in Denmark. We develop software, hardware, mechanics, signal processing, and advanced algorithms.
company and the colleges always
When it comes to research, we have collaborated with the Technical University of Denmark (DTU) for more
strives for achieving better.”
than 20 years. Together, we have completed 2 high technology projects for advanced ultrasound imaging.
- Rasmus H. Rossen,
We are currently part of a large-scale project with DTU, Danish hospital Rigshospitalet, and the University
Senior Mechanical Engineer
of Copenhagen concerning extreme high-resolution ultrasound.
Apply for the position:
[email protected]
Mark the application:
“MDR Program Director”
We conduct interviews as we receive applications