Archive for July, 2015

Senior Regulatory Consultant with Team Leader Potential

Web-sub

Would you like to be part of a team ensuring the highest levels of patient safety by 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 for our RA & Quality Team.

Your Job and Key Responsibilities
Reporting directly to the Managing Director you will lead and develop the RA & Quality Team as well as interact with our customers with regards to both generating opportunities as well as hands-on RA & QA assignments.

Bringing our customers products to market – requires your – and your team’s, solid competence with regards to both the CE mark approval, CE testing for Medical Devices (MDD) processes as well as the processes required for FDA, 510K registration plus PMA.

Desired Skills and Experience
Our preferred candidate has the following personal and professional qualifications:

Qualifications
– Relevant pharmaceutical or engineering degree, B.Sc or M.Sc
– Minimum 5 years of experience in related position
– Firm knowledge of CE mark approval, CE testing for Medical Devices (MDD) as well as FDA, 510K registration and PMA
– Training/teaching experience is seen as an advantage but not a requirement

Competencies (Professional as well as Personal)
– Solution oriented with an excellent ability to identify cost-effective angels to regulatory requirements and quality assurance demands
– You have a very strong collaborative approach towards the stakeholders
– You are a good listener with strong communicative skills
– Strong cultural awareness and a global mindset
– Fluency in English and at least one other Scandinavian language
– Leadership skills and a motivating appreciative approach to people management
– Outgoing personality with the skills to facilitate and lead projects


What we offer

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.

Contact information
If you want to know more about the job you are welcome to contact Michael Funder on +45 2064 4146 or mf@medicologic.com

Send your application
Send your application including CV to CEO, Michael Funder mf@medicologic.com. Deadline is Jan 15, 2015.
We will conduct interviews on an ongoing basis.

We look forward to hearing from you.

Download as pdf