Regulatory Affiars Associate (Maternity Leave Cover)

Send your application in English to:
[email protected]
Mark the application:
“Regulatory Affairs Associate”
We conduct interviews as we receive
applications
Regulatory Affairs Associate
Maternity leave position
12 months
Do you want to secure safe and effective new products for
Health Care Providers utilizing intraoperative ultrasound
imaging around the globe?
Regulatory Affairs Associate - Maternity leave
You:
We are looking for a Regulatory Affairs Associate with
drive and energy to join our Regulatory Affairs team. It is
Have a scientific background from eg. DTU, KU
a temporary position (12 months) in a rapidly increasing
Science or the like
organization. You will be part of our global team who are
Have good planning and communication skills
located in Denmark, UK, Boston, USA and in Shanghai,
China. Write and speak English at Native speaker level
Have experience with international collaboration
We are looking for a new team member with a positive
and proactive mindset. You thrive in an international
Have experience with development of medical
environment with a high pace. You enjoy being part of a
devices
committed team and take pride in finalizing the tasks
Have preferably 2 years experience of registering
together with the team.
medical devices
In this position you will initiate and support local
This job will provide you with the opportunity to learn
registrations of innovative products around the globe and
more about global Medical Device regulation.
be part of the group who ensure that BK Medical products
are timely registered in order to be provided to our global
If these challenges are interesting for you, please send
customers. You will plan, author and execute documents your application to:
[email protected]
with the aim of registering products globally.
You will work closely with the Global Regulatory team as
Mark the application:
well as Product Marketing, Sales Distribution and R&D.
“Regulatory Affairs Associate”
We conduct interviews as we receive applications.
Global Regulatory Affair
Susanne Faarbæk
Director Regulatory Affairs
+ 45 31
Regulatory Affairs is a part 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 15 members: 4 people in US, 1
in China, 2 in UK and 8 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 our global
customers.
We are responsible for providing early Regulatory Strategies during
development of new products as well as ensuring CE marking, FDA clearance
and product registration in 70 countries. We communicate with local Authorities
around the globe and secure compliance to local regulation as well as keeping
the organization informed about changes.
We work closely with R&D which is located in Denmark, as well as Clinical and
Commercial Marketing, Marketing Communication, Product Strategy groups and
Global Distribution Sales.
We have a great team that solve challenging tasks together. We value being
professional, trustworthy, honest, communicate with one voice and being open
minded. We are business oriented and take pride in guiding the organization in
the complex regulatory environment.
Does this resonate with you? And would you like to be part of our team?
Apply for the position today.
Innovative Products
We are looking for employees who are as driven and
motivated as we are. Employees who are passionate
about developing products that can help doctors make
decisions to improve patients’ quality of life
Below are some of the many products we are proud to
have developed.
Our products are
designed for ultrasound
examinations in:
Surgery
Urology
Pelvic Floor
Colorectal
The Robotic Drop-In ultrasound transducer is
used during surgical procedures to visualize
organs. It is inserted through a trocar in the
abdomen and can be controlled by a robot.
The ultrasound images help the surgeon in
decision making during surgery.
The bkSpecto is our latest
development. This unique scanner
has very high image quality as well
as an easy-to-use glass interface
Send your application in English to: Mark the application: “Technical Documentation Manager”
[email protected] We conduct interviews as we receive applications
BK Medical
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.
As market leaders, we work closely with experts and universities to provide the best solutions to clinical challenges.
Research and Development
BK Medical has development departments in Denmark, the US, and Canada. The largest development team is based in Denmark with approximately
80 employees, while there are 24 employees in State College, Pennsylvania, and 11 in Vancouver, Canada. We do development in software, hardware,
mechanics, signal processing, and advanced algorithms.
When it comes to research, we have collaborated with the Technical University of Denmark (DTU) for more than 20 years. Together, we have
completed 2 high technology projects for advanced ultrasound imaging. We are currently part of a large-scale project with DTU, Danish hospital
Rigshospitalet, and the University of Copenhagen concerning extreme high-resolution ultrasound.
Global Organization
BK Medical is an international company with sales offices all over the world, and European headquarters in Herlev, Copenhagen. We have
approximately 630 employees, 170 in Herlev. In 2020, we booked revenue of USD 163 million.
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 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.
Apply for the position:
[email protected]
Mark the application:
“Regulatory Affairs Associate”
We conduct interviews as we receive applications