Senior Clinical Scientist

Senior Clinical Scientist Join BK Medical to help develop our growing team in Clinical Development.
Together with Clinical Application and Clinical Outcomes, Clinical Development is one of the three specialized teams that make up our Department of Clinical Value Proposition and Evidence.
This is your opportunity to become part of an innovative team, where your work has a real impact on people’s lives around the world.
Our Clinical Development team currently consist of 3 experienced Clinical Scientists and Clinical Evidence Leads. Our main responsibilities are to drive the clinical strategies to ensure timely execution on clinical deliverables to support regulatory submissions and commercial strategies. As Senior Clinical Scientist you will be driving clinical submission documentation and strategies in close collaboration with the Clinical Evidence Lead and cross functional stakeholders.

We are an international team who values cultural and personal diversity in an informal, friendly, and respectful atmosphere. We strive to apply data driven methodologies and evidence-based decision making in our daily work. At the same time, we value a balanced and pragmatic approach to problem solving in a fast-growing company in a dynamic environment.

Key responsibilities for our new Senior Clinical Scientist

• Execute clinical evaluation and documentation activities, including clinical input to PMCF and PMS.
• Provide clinical support to global registrations.
• Support and drive ad hoc clinical activities and problem solving.

Your typical tasks will include

• Create and maintain Clinical Evaluation Reports (CERs) to meet the requirements of the MDR.
• Drive and maintain the clinical evaluation process to meet regulatory requirements.
• Provide clinical support for global registrations.
• Maintain overview of published scientific literature within their field.
• Review, analyze, and communicate scientific literature.
• Review, analyze, and communicate clinical data.
• Provide sound scientific and technical advice during product development phase.
• Assist the engineering team by providing input during risk management assessment process which involves product safety and usability from a clinical perspective.
• Provide input to PMCF (Post Market Clinical Follow up) and post market surveillance processes.

Your professional background
You bring a B.S. or higher degree in the Life Sciences or related disciplines + several years of experience conducting clinical evaluations

• Demonstrated expert knowledge and comprehensive understanding of applicable GCP, ICH guidelines, FDA and MDR regulations as well as applicable international guidelines
• Excellent interpersonal, written/verbal communication & organizational skills
• Fluent in verbal and written English language
• Willing to travel domestically and internationally, as required

Our mission at BK Medical is to change the standard of care in surgical interventions with real-time visual guidance. You will become part of a true innovator in the MedTech industry with 800 colleagues in Denmark, the United States, and other locations around the world. Now, we are advancing our mission as part of GE HealthCare. This puts us in a position where we can think even bigger and unlock new opportunities for us, surgeons, and their patients. It’s a great time to join us!

GE Healthcare is a leading global medical technology and digital solutions innovator. The mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

We are an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

BK Medical’s European Headquarters are in Herlev, Denmark, with more than 300 employees. The work atmosphere is casual, and our organizational structure is flat. We have a good staff canteen focusing on health and variety, private health insurance and pension plans, as well as social events and several staff clubs.

We look forward to receiving your application, in which you describe:

• Your motivation for becoming part of our Clinical Development team
• Your experience and skills that are particularly relevant to the role