Help us HAMAPASAP!
In order to Help As Many As Possible As Soon As Possible (HAMAPASAP) we are looking for an Regulatory Affairs (RA) Officer at our location in Bilthoven.
Your role at Micreos
As our business keeps growing we are looking for an ambitious and enthusiastic RA Officer with 1 to 2 years of experience in Medical Devices industry. In this role you are responsible for the regulatory process for products of Micreos Human Health requiring governmental approval by ensuring that all necessary applications are filed. The role reports into the RA Manager.
As RA Officer your main responsibilities will be to:
Maintenance and update of technical documentation during the product’s life-cycle by:
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Contributing in compiling technical documentation according to the Annex I – II of the Medical Device Regulation 2017/745 (MDR)
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Keep the regulatory overviews updated by performing annual gap assessments on applicable harmonized standards and guideline
Assisting in the development of regulatory compliant procedures for Micreos Human Health by:
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Providing regulatory assistance in compliance with requirements of the MDR identification and remediation of gaps
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Interpret regulatory rules and provide assistance in communicating the changes through policies and procedures in collaboration with Quality Assurance department
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Independent in performing research regarding updates in Medical Device related regulatory requirements
Contributing in setting up and implementing processes in line with the MDR to safeguard the safety of the Medical Devices
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Provide assistance in keeping medical device documents (e.g. Clinical Evaluation and Post Marketing Surveillance etc.) updated according to the Medical Device Regulation 2017/745
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Acquainted with ISO13485 and requirements regarding the Quality Management System and Standing Operating Procedures (SOP)
More about you and your competences
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Preferably a WO diploma in biological/pharmaceutical sciences or equivalent
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Result orientation: you focus on improving performance
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Strategic orientation: you see the big picture, recognize underlying trends, patterns or connections between apparently unrelated situations.
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Communication skills: you adopt a "win-win" approach to negotiation, argues skilfully and uses a range of approaches and techniques to influence, persuade or gain the support / co-operation of others.
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Team skills: you contribute towards team goal by working co-operatively with others, also gets people's input to decisions/plans, and promotes team spirit.
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… and finally you don’t have a 09:00-17:00 mindset!
Our offer
Micreos offers a varied full time role within a young and enthusiastic team. The salary offered is in line with market conditions and you will be given the opportunity to make the fullest use of your talents. We offer you an ambitious and pleasant international working environment.
Is this the role you are looking for?
Our Micreos HR team is looking forward to receiving your CV and cover letter via recruitment@micreos.com
Please only apply if you are eligible to work in the Netherlands.
Company profile:
Bacteria are all around us. Most of them are good and protect us, but some can cause irritation or infection. Antibiotics do not distinguish between good and bad bacteria and their use can lead to side effects and resistance. As they have been broadly used - often inappropriately - the emergence of antibiotic-resistant 'superbugs' is now a global concern. On the other hand, it has become evident that our microbiome, comprising billions of beneficial bacteria, is necessary for our health and should be left intact.
Micreos develops the world's first targeted antibacterial products, set to replace antibiotics. The company is viewed as global leader spearheading this exciting new field. With Micreos endolysin technology, for the first time we can kill only the unwanted bacteria - including antibiotic resistant strains - while leaving the beneficial bacteria intact. In addition, research shows that the use of endolysins does not induce resistance. This unlocks a completely new approach in dealing with the bacteria around us - also enabling daily use, as long as needed while preserving the important biodiversity on our skin and in our gut. Based on its technology platform, Micreos has launched several products for inflammatory skin conditions such as acne, eczema and rosacea (brandname: Gladskin) and several food safety products marketed under the Phageguard brand. Micreos is also developing pharmaceutical products. See also www.micreos.com and www.gladskin.com
Acquisitions following this vacancy are not appreciated.