Save Job Back to Search Job Description Summary Similar Jobs Added 08/04/2025Specialist Quality Management & Regulatory Affairs EuropeSomnomed Medical Devices EuropeAbout Our ClientSomnoMed, founded in 2004, is an Australian Stock Exchange-listed medical device company operating in 28 countries. Headquartered in Sydney, Australia, with offices in Europe and the United States, SomnoMed focuses on the development and production of clinically proven medical devices for the treatment of obstructive sleep apnea (OSA). More than 950,000 patients worldwide with mild to moderate OSA have been successfully treated with SomnoDent MRAs.Job DescriptionOverseeing and managing quality and regulatory affairs within the organisation.Ensuring compliance with industry and global regulatory standards.Developing and implementing quality management systems (QMS).Liaising with internal and external stakeholders on regulatory affairs.Conducting audits and inspections to maintain quality assurance.Conducting trend analysis and Post Market Surveillance (PMS) activities.Providing training and guidance to staff on quality and regulatory matters.Keeping up-to-date with changes in regulatory legislation and guidelines.Preparing and submitting regulatory documents.Actively contribute to the upcoming implementation of a global eQMS.The Successful ApplicantA successful QARA Specialist should have:A strong educational background in Lifesciences, MDR or IVD experienced.Proficiency in English. Other language, such as German, Dutch, French, is a plus.In-depth knowledge of global regulatory affairs and quality management systems, with a mandatory emphasize on ISO13485 and MDR.Excellent communication, organisational and project management skills.Strong problem-solving and decision-making abilities.The ability to work well in a team and independently.What's on OfferOur client offers you:A competitive salary rangeThe opportunity to work in a supportive and professional environment, adding value to a global QARA team and the entire organization.A position that enables work on remote, and punctually, travels to our European entitiesThe chance to make a real difference in the medical device industry.ContactRikkert KempenQuote job refJN-032025-6693541Job summarySectorHealthcare & Life SciencesSub SectorSalesIndustryHealthcare / Pharmaceutical Jobs by locationNetherlandsContract TypePermanentConsultantRikkert KempenJob ReferenceJN-032025-6693541Remote or officeWork from home
