Senior RA Specialist for Label & Traceability, BK Medical / 1812 / CLOSED

The Company.
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 is 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.

Senior RA Specialist for Label & Traceability

• A market leader with customized products for surgical procedures 
• You will drive regulatory Label strategies & secure traceability.
• You have a positive mindset working with class I-III Medical Device globally.

The Challenge
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.

In this position you will both drive global regulatory label strategy and secure traceability for new innovative products and also life cycle management of product around the globe. You will be responsible for Eudamed Registration in EU according to MDR. Working with Life cycle management of product also includes e.g. significant assessment of changes and SAP product restriction.

We are looking for a candidate with drive and energy to join the Regulatory Affairs team in Herlev. It is a position in a rapidly increasing organization. You will be part of a global team situated in Denmark, USA and China. You must thrive in this international environment working with a high pace, being part of a committed team that take pride in finalizing tasks together. You contribution will be a positive and proactive mindset. All these tasks will be carried out in cooperation with the Director for RA, Global RA, R&D and Production              

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.

Your Talent
You have a degree on Bachelor level in Medical Science, Engineering, or equivalent knowledge. You have 3-5 years’ experience in a similar position in an international Medical Device company.

• You have been working with Regulatory Label Strategy and created and maintained life cycle management activities such as significant assessment of change, registration, SAP restriction of product.
• Experience in UDI and Eudamed preferred.
• Experienced in cooperation with relevant national health authorities, 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

The successful candidate has high quality standards and is committed to meet deadlines. In addition, you are well organized, pro-active, flexible and can work on multiple tasks.

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. 

The Organization and Team
The global Regulatory Affairs is a part 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 9 people in Denmark. The RA Director is also located at Herlev site. The members of 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 responsible for providing early Regulatory Strategies during development of new products as communicate with local Authorities around the globe and secure compliance to local regulation as well as keeping the organization informed about changes.

The Team works closely with R&D located in Denmark, as well as Clinical and Commercial Marketing, Marketing Communication, Product Strategy groups and Global Distribution Sales.

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. The Team 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 Senior RA Specialist for Label & Traceability? They offer an exciting job in an international company with great influence and responsibility. Your contributions will be greatly valued.                   

Application
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 “1812/Senior RA Specialist” by way of e-mail to job@besttalent.dk  You can read more about Best Talent at www.besttalent.dk.