Help us HAMAPASAP!
To hamapasap! (help as many as possible as soon as possible) with our innovative technology by safeguarding a customer-centric medical approach, commiting to the highest standards in the industry whilst keeping the commercial objectives in scope within an MDR environment, we are looking for a Medical Advisor.
Your role at Micreos
You are responsible for evaluating medical safety risks across the business portfolio to enable informed customer-centric decisions.
Main objectives of the role
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Safeguard customer safety through relevant processes including Risk Management, Health Hazard Evaluations, Risk-Benefit analyses, complaints, recalls, review of post-market surveillance data to evaluate trends, etc.
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Provide authoritative medical support to all teams involved including: R&D, Regulatory Affairs, Quality, Legal and Communications.
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Contribute to risk management plans and failure mode analysis during product development, safety signal detection and post-market surveillance.
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Participate in clinical safety discussions with KOLs, regulatory agencies including during regulatory inspections.
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Provide input and review all applicable medical and scientific information
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Provide medical review of clinical evaluation plans and reports
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Provide medical content for marketing and communication and review all promotional issues, and other corporate activities relating to dissemination of scientific information to internal stakeholders and external customers.
More about you and your competences
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A diploma or certificate or other types of evidence of formal qualification awarded by a university in medicine, pharmacy, or other relevant fields, or equivalent with 10+ years of medical experience, and/or at least 5+ years medical safety experience in medical device / biotech industry in medical affairs/clinical affairs /R&D roles.
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Strong background and deep medical expertise in the assessment of clinical risk-benefit throughout product development life-cycle
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Deep knowledge and understanding of all applicable standards / regulations requiring medical input, such as risk management, complaint management, reporting requirements, etc.
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Shown ability to be a strong advocate for customer-centric decision making
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Ability to provide independent, medical input to critically evaluate clinical risk, and make evidence-based risk benefit determinations
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Lead medical input into critical business decisions regarding potential customer safety issues
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Analysis & interpretation of market signals & trends from various resources including clinical data, literature, customer feedback etc.
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Language skills in Dutch & English (written and spoken)
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.