Medical Advisor Medical Devices
- Medical Devices
- Vast (1,0 fte)
- Midden Nederland
- Medical Devices bedrijf in het midden van het land
Are you looking to become a Medical Advisor for medical devices? Take on the responsibility of evaluating medical safety risks across the business portfolio and enable informed customer centric decisions. Conside this opportunity, commit to the highest standards in the industry whilst keeping the commercial objectives in scope within an MDR environment.
- 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.
- Provide authoritative medical support to all teams involved including: R&D, Regulatory Affairs, Quality, Legal and Communications.
- Contribute to risk management plans and failure mode analysis during product development, safety signal detection and post-market surveillance.
- Participate in clinical safety discussions with KOLs, regulatory agencies / notified bodies, including during regulatory inspections.
- Provide input and review all applicable medical and scientific information
- Provide medical review of clinical evaluation plans and reports
- 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.
- 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.
- Strong background and deep medical expertise in the assessment of clinical risk-benefit throughout product development life-cycle
- Deep knowledge and understanding of all applicable standards / regulations requiring medical input, such as risk management, complaint management, reporting requirements, etc.
- Shown ability to be a strong advocate for customer-centric decision making
- Ability to provide independent, medical input to critically evaluate clinical risk, and make evidence-based risk benefit determinations
- Lead medical input into critical business decisions regarding potential customer safety issues
- Analysis & interpretation of market signals & trends from various resources including clinical data, literature, customer feedback etc.
Language skills in Dutch & English (written and spoken)
Our client 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.
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