Senior Regulatory Affairs Specialist, Medical Devices/1792/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 Medical supports employees in developing their skills and expertise and have a professional and informal organization with flexible working conditions and a flat organizational structure.

BK Medicals employees are effective and can execute ideas into strong products – these ingredients make them an exciting and development-oriented workplace.

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 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 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 position as Senior Regulatory Specialist? They offer an exciting job in an international company with great influence and responsibility. Your contributions will be valued and define how you are going to work in the future.

Senior Regulatory Affairs Specialist, Medical Devices
Skilled & dedicated with potential to become Project Leader

• A market leader with customized products for surgical procedures
• You will be working with regulatory strategies for Medical Devices Class I - III globally
• You have influence and work with a broad diversity of products and projects

The Challenge
Do you want to secure safe and effective new products for Health Care Providers utilizing intraoperative ultrasound imaging around the globe? It is a new position in a rapidly increasing organization and on behalf of BK Medical, Best Talent is now looking for a Senior Regulatory Affairs Specialist with drive and energy to join the Regulatory Affairs team. You will be part of the global team who is situated in Denmark (Herlev), USA (Boston) and in China (Shanghai).

In this position you will drive global registrations of new innovative products around the globe and be part of the group who ensure, that BK Medical products are timely registered to be provided to their global customers. You will plan RA strategy, author, and execute documents with the aim of registering products Class I - III globally.

We are looking for a team member with a positive and proactive mindset. You enjoy being part of a committed team and take pride in finalizing the tasks together. You also thrive in an international environment where you will work closely with the Global Regulatory team as well as Product Marketing, R&D and Sales Distribution.

Do you dream of a job where you are part of a great RA team in an informal work 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.

Your Talent
You have a degree on Bachelor level in Medical Science, Engineering or equivalent knowledge. You have more than 5 years’ experience in a similar position in an international Medical Device company. You have been working with Regulatory Strategies during development of new products as well as ensuring CE marking (MDR), FDA 510(K) clearance and product registration. Experiences in Medical Claims on Labeling and Promotional Materials will also be an advance. You have a solid experience in cooperation with relevant national health authorities and Notified Body. The seniority will be assessed based on your qualifications.

As a person you thrive on working in an environment with a diversity of people, products and projects. You integrate well into a team as well as working independently on an assignment. Experience working as a Project Leader will be an asset.

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.

Excellent knowledge of MS Office and fluency in English with good verbal and written communication skills is a given. 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.

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 “1792/RA” by way of
e-mail to job@besttalent.dk You can read more about Best Talent at www.besttalent.dk.