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Senior Regulatory Consultant with Team Leader Potential


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:

– 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

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

We look forward to hearing from you.

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Rasmus Funk has joined our R&D team

_MG_0534 webWith a view to the company’s continued development and positive growth within Research and development, we expanded our R&D team with Rasmus Funk.

Rasmus has more than 5 years of experience with medical device product development. He has expert knowledge on single use devices and surgical equipment.

His expertise ranges from the front end requirement mapping and conceptualization through to final production setup.

By helping many projects getting from idea to product Rasmus has gained extensive knowledge on Design for Manufacturability. Especially through cost optimization of products in the competitive single use medical device market.

Rasmus has great experience with minimal invasive instruments and thus also the challenge of manufacturing micromechanical components while ensuring tolerance based robust functionality. He also has great knowledge on cutting edge additive manufacturing and rapid prototyping technologies.

Rasmus has an education in Mechanical Engineering from the Technical University of Denmark with an emphasis on user driven product development and design.

Fast track for Fertility Test for Men


MotilityCount and the consultancy company Medicologic have obtained CE approval for SwimCount in just three quarters of a year. This was accomplished through a smooth cooperation between the two companies. Medicologic was clear in its communication on which documentation was required, and MotilityCount delivered it.

In connection with the CE approval and the launch of SwimCount, which is the world’s first reliable home test of men’s sperm quality, Medicologic contributed with their expertise in gathering and writing the documentation required by the British Standards Institution (BSI).

_MG_0411 web

– Having secured the CE approval, we are now ready to sell SwimCount from our website, says CEO Jacob Moellenbach, MotilityCount. – We are also well underway in concluding sales agreements with Danish and British customers.

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Never before – but I will do it again

It takes heart – and a good pair of legs – to ride to Paris on a bike in only 7 days. Medicologic easily agreed to sponsor Stig Jørgensen, CEO of Medicon Valley Alliance, when he joined Team Rynkeby in the now classical charity-ride to raise money for the Child Cancer Foundation.

In 2014, Team Rynkeby donated DKK 36.128 million to the fight against childhood cancer – of which DKK 23.498 million went to the Danish childhood cancer foundation, Børnecancerfonden.

In 2014, Team Rynkeby donated DKK 36.128 million to the fight against childhood cancer – of which DKK 23.498 million went to the Danish childhood cancer foundation, Børnecancerfonden.

In his late fifties, Stig Jørgensen has never before enjoyed cycling as a sport. Now, he has been training twice weekly at spinning since November and with the coming of spring has continued training outdoors. By early July, Stig and his teammates from Rigshospitalet – Team Riget – will be able to ride the approximately 1,200 kilometers from Copenhagen to Paris in just 7 days.

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More manpower to our QA/RA team

With a view to the company’s continued development and positive growth within Regulatory Affairs, we expanded our QA/RA team with Pernille Holm beginning March.

Pernille Holm, QA/RA assistant, Medicologic

Pernille Holm, QA/RA assistant, Medicologic

Pernille Holm started as QA/RA assistant on March 1, 2015.

Pernille has an education in Material Science and Process Technology from the Technical University of Denmark and her main focus was corrosion of electronics and surface technology.

She has more than 10 years of experience with quality control of medical devices. For the last year she worked with quality assurance and process optimization within the construction material industry.

Pernille has worked and done projects in different industries from hearing aids over blades for wind turbines to aero engines. In the construction material industry Pernille worked with optimization of the production in order to reduce energy consumption while maintaining the quality of the product.

Pernille will support our customers in documentation, process mapping, Quality management systems and documents for CE marking of products.

Contact details

Outsourcing – a Smooth Operation

Outsourcing is often a cost efficient solution. QMS is no exception. When Otovation decided to outsource their quality management for their entire line of equipment for hearing aids, they chose Medicologic as a partner.

Quality management is essential in the medical device industry as the prerequisite for permission to market products as stated for instance in the EU Medical Device Directive (MDD).

With ever-changing standards and regulatory demands from the health authorities, staying updated can be quite a demanding task for a company’s quality management department. Rather than building and maintaining this expertise in-house, you can hire it from a consultant.

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Invitation til reception

Frank-Petersen-WebnyhedI anledning af Frank Petersens 65 års fødselsdag vil vi gerne invitere til en uformel reception hos Medicologic:

Torsdag den 26.03.15, kl. 15.00 – 17.00

Arne Jacobsens Allé 15-17,
2300 København S

Vi glæder os til at se jer.

Med venlig hilsen
Michael Funder, Medicologic

Praktisk info:
Parkering er mulig overfor i Fields.
I kan benytte indgangen ved nr. 17 (tættest på Metroen)
Vi holder til på 5. sal.