Would you like to be part of a team ensuring the highest levels of patient safety? You will be contributing to the development and approval of intelligent and innovative treatment methods within the medtech industry.
Medicologic is a leading Danish medtech consultancy and engineering company. Together with our customers we bring new and innovative products on the market on time.
We are growing and thus need additional resources.
With a strong pipeline of challenging projects we are seeking a passionate Quality Consultant to join our QA/RA team in Copenhagen. Reporting to the Team Manager you will be part of our RA & Quality team; interact with customers to generate opportunities and hands-on RA assignments. To begin with you will be the working both with RA and QA, but as we grow, focus can be placed where you and the organization gains most benefit.
Bringing customer products to the market require that you have solid competences about CE marking of medical devices and knowledge of establishing compliance to the Essential Requirements. Knowledge of FDA’s Quality System Regulation and on how to bring medical devices on the US market (510(K) registration and Pre-Market Approval – PMA) is required.
Desired Skills and Experience
Our preferred candidate has the following professional and personal qualifications:
• Relevant degree in pharmaceuticals or engineering (B.Sc. or M.Sc.)
• Minimum 5 years of experience in relevant positions
• Knowledge of CE marking of medical devices, Quality Management Systems, and 510(K) registration and Pre-Market Approval (PMA)
• Knowledge of and experienced with MDD and IVD requirements
• Training and teaching experience is an advantage
Competencies (professional and personal)
• Solution oriented with an excellent ability to identify a cost-effective approach to regulatory assignments
• Have a strong collaborative approach towards stakeholders
• A good listener with strong communicative skills
• Strong cultural awareness and a global mindset
• Fluency in English and one other Scandinavian language
• Outgoing personality with skills to facilitate and lead projects
We offer a challenging environment with build in opportunities for growth both professional as well as personal. We are a company with growth potential and concrete growth plans. Our customer centric approach to consultancy gives you an insight into cutting edge development both in Denmark and internationally.
We would like to welcome you in our engaged, warm, positive, fast and professional environment with social events amongst colleagues as well as professional sparring from highly experienced experts in order for you to have an engaged daily work experience as well as professional growth opportunities while working. Also we offer a competitive compensation package with both pension and insurances.
If you want to know more about the job you are welcome to contact CEO, Michael Funder on +45 2064 4146 or firstname.lastname@example.org
Send your application
Send your application including CV to CEO, Michael Funder email@example.com.