Senior Regulatory Affairs Specialist

Send your application in English to:
[email protected]
Mark the application:
“Senior Regulatory Affairs Specialist”
We conduct interviews as we receive
applications
Senior Regulatory Affairs
Specialist
Do you want to secure safe and effective new products for Health
Care Providers utilizing intraoperative ultrasound imaging around
the globe?
Senior Regulatory Affairs Specialist
We are looking for Senior Regulatory Affairs Specialist with drive and Who are we in RA
energy to join our Regulatory Affairs team. It is a new position in a Regulatory Affairs is a part the RA/QA Function belonging to the global
rapidly increasing organization. You will be part of our global team who organization with offices in Herlev, Denmark and the Global
are in Denmark (Herlev), USA (Boston) and in China (Shanghai). Headquarter in Boston, Massachusetts, US.
The Global Regulatory Affairs Team consists of 13 members: 3 people
We are looking for a new team member with a positive and proactive in US, 1 in China, 9 people in Denmark. The members of the
mindset. You thrive in an international environment with a high pace. Regulatory Affairs have a strong regulatory background within Medical
You enjoy being part of a committed team and take pride in finalizing the Devices and are dedicated to development of safe and effective
tasks together with the team. In this position you will drive global products for our global customers.
registrations of innovative products around the globe and be part of the We have a great team that solve challenging tasks together. We value
group who ensure that BK Medical products are timely registered to be being professional, trustworthy, honest, communicate with one voice
provided to our global customers. You will plan RA strategy, author and and being open minded. We are business oriented and take pride in
execute documents with the aim of registering products Class I - III guiding the organization in the complex regulatory environment.
globally.
You will work closely with the Global Regulatory team as well as Product About BK Medical
Marketing, Sales Distribution and R&D. BK Medical is committed to designing ultrasound systems that help
surgeons image, guide, intervene, and navigate inside the human
You: body. Surgeons are our customers, and they range from HPB
• Degree on bachelor level in medical science, engineering or surgeons, neurosurgeons, and robotic-assisted surgeons to urologists,
equivalent knowledge colorectal surgeons, and more.
• More than 5years’ experience in a similar position in an international Our mission at BK is to enable real-time intraoperative guidance during
medical device company surgical procedures, giving surgeons the information needed to
• Have experience with making Regulatory Strategies during immediately make critical decisions. Our products are designed and
development of new products as well as ensuring CE marking, FDA customized for surgical procedures, to help surgeons save time and
clearance and product registration get results.
• Experience in software/digital fields preferred As market leaders, we work closely with experts and universities to
• Experienced in cooperation with relevant national health authorities, provide the best solutions to clinical challenges.
Notified Body
• Ability to communicate well verbally and in writing is essential, as are
good organizational and planning skills
• Fluent in oral and written in English as a working language
Global Regulatory Affairs
Lis Pedersen Mylin
Director Regulatory Affairs
+ 45 31 43 24 15
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 13 members: 3 people in US, 1
in China, 9 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 fit you well? 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 surgeons make decisions that can improve outcomes for
patients.
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 one of our latest
developments. This unique scanner has
very high image quality as well as an
easy-to-use glass interface
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 and the US. The largest development team is based in Denmark with approximately 100
employees, while there are 11 employees in State College, Pennsylvania. 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 670 employees, 210 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:
“Senior Regulatory Affairs Specialist”
We conduct interviews as we receive applications