{"id":12027,"date":"2025-05-08T21:51:41","date_gmt":"2025-05-08T19:51:41","guid":{"rendered":"https:\/\/www.fysiologic.nl\/?p=12027"},"modified":"2025-05-08T22:06:53","modified_gmt":"2025-05-08T20:06:53","slug":"sales-representative-voor-fysiologic-dgtl-copy","status":"publish","type":"post","link":"https:\/\/www.fysiologic.nl\/tr\/sales-representative-voor-fysiologic-dgtl-copy\/","title":{"rendered":"FYSIOLOGIC IS LOOKING FOR A QA\/RA SPECIALIST (32\u201340 HOURS)"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"12027\" class=\"elementor elementor-12027\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"ob-is-breaking-bad elementor-section elementor-top-section elementor-element elementor-element-344ae598 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"344ae598\" data-element_type=\"section\" data-settings=\"{&quot;_ob_bbad_use_it&quot;:&quot;yes&quot;,&quot;_ob_bbad_sssic_use&quot;:&quot;no&quot;,&quot;_ob_glider_is_slider&quot;:&quot;no&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5ae18c02\" data-id=\"5ae18c02\" data-element_type=\"column\" data-settings=\"{&quot;_ob_bbad_is_stalker&quot;:&quot;no&quot;,&quot;_ob_teleporter_use&quot;:false,&quot;_ob_column_hoveranimator&quot;:&quot;no&quot;,&quot;_ob_column_has_pseudo&quot;:&quot;no&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1596c8f4 ob-harakiri-inherit ob-has-background-overlay elementor-widget elementor-widget-text-editor\" data-id=\"1596c8f4\" data-element_type=\"widget\" data-settings=\"{&quot;_ob_use_harakiri&quot;:&quot;yes&quot;,&quot;_ob_harakiri_writing_mode&quot;:&quot;inherit&quot;,&quot;_ob_postman_use&quot;:&quot;no&quot;,&quot;_ob_perspektive_use&quot;:&quot;no&quot;,&quot;_ob_poopart_use&quot;:&quot;yes&quot;,&quot;_ob_shadough_use&quot;:&quot;no&quot;,&quot;_ob_allow_hoveranimator&quot;:&quot;no&quot;,&quot;_ob_widget_stalker_use&quot;:&quot;no&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\n<figure class=\"wp-block-image aligncenter\"><img fetchpriority=\"high\" decoding=\"async\" width=\"300\" height=\"249\" class=\"wp-image-11812\" src=\"https:\/\/www.fysiologic.nl\/wp-content\/uploads\/2024\/12\/job_ad_image-1-300x249.png\" alt=\"\" srcset=\"https:\/\/www.fysiologic.nl\/wp-content\/uploads\/2024\/12\/job_ad_image-1-300x249.png 300w, https:\/\/www.fysiologic.nl\/wp-content\/uploads\/2024\/12\/job_ad_image-1-768x639.png 768w, https:\/\/www.fysiologic.nl\/wp-content\/uploads\/2024\/12\/job_ad_image-1-14x12.png 14w, https:\/\/www.fysiologic.nl\/wp-content\/uploads\/2024\/12\/job_ad_image-1.png 796w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/figure>\n\n<p>Are you passionate about Quality and Regulatory Affairs and working for an innovative MedTech company?<br \/>Fysiologic, a market leader in cardiac diagnostics, is looking for a meticulous and experienced professional with an eye for detail and a passion for quality and regulatory compliance.<br \/>As a Quality &amp; Regulatory Specialist, you will play a key role in ensuring our product quality and compliance with national and international laws and regulations.<br \/>In this role, you\u2019ll be essential in\u00a0 supporting our fast-growing organization by laying a solid foundation in quality and regulatory affairs. Fysiologic is part of ACE Health AB, a pioneer in cardiac care. ACE Health AB is a scale-up with\u00a0 international growth ambitions through acquisitions and partnerships on a global scale, meaning this role will also contribute to international acquisition processes.<br \/>Ready to take the next step in your career?<br \/>We\u2019d love to hear from you!<\/p>\n<p><strong>ABOUT US<\/strong><br \/>Fysiologic Smart ECG Solutions specializes in ECG diagnostics.<br \/>We began recording and analyzing ECGs in 1977 for general practitioners, specialists, and hospitals. That means we\u2019ve now performed over two million analyses-a number that continues to grow exponentially.<br \/>Driven by our passion for ECGs, we continuously expand our knowledge and introduce new forms of diagnostics. Many of the products, both software and hardware, are developed and produced in-house.<\/p>\n<p><strong>REQUIREMENTS<\/strong><br \/>A successful QA\/RA Specialist should have:<\/p>\n<ul>\n<li>A completed bachelor\u2019s or master\u2019s degree (HBO\/WO), preferably in a technical, biomedical, or related field.<\/li>\n<li>At least 2 years of experience in a similar role.<\/li>\n<li>Excellent command of Dutch and English, both spoken and written.<\/li>\n<li>Demonstrated knowledge of international medical device regulations, including ISO 13485, EU MDR (2017\/745), EU IVDR ( 2017\/746) and preferably FDA 21 CFR Part 820.<\/li>\n<li>Strong communication, organizational, and project management skills.<\/li>\n<li>A proactive, detail-oriented mindset and the ability to work collaboratively across departments.<\/li>\n<\/ul>\n<p><br \/><strong>WHAT WE OFFER<\/strong><br \/>A competitive salary with plenty of opportunities for growth. You&#8217;ll work in a friendly, professional, and driven team.<\/p>\n<p><strong>YOUR RESPONSIBILITIES<\/strong><br \/>This role involves a wide range of responsibilities, including:<\/p>\n<ul>\n<li>Monitor international regulatory requirements and advise internal teams on implications for product development and compliance.<\/li>\n<li>Staying informed about regulatory changes and advising internal stakeholders on laws, regulations, and guidelines.<\/li>\n<li>Manage product registrations and submissions to ensure timely approval and successful market launches.<\/li>\n<li>Implement, maintain, and continuously improve the quality management system in compliance with ISO 13485 and applicable regulations.<\/li>\n<li>Serve as the primary contact for regulatory agencies and notified bodies.<\/li>\n<li>Handling product complaints and maintaining overall responsibility for products within the quality management system.<\/li>\n<li>Acting as the point of contact for quality and compliance matters.<br \/>Handle product complaints and coordinate investigations, CAPA, and reporting activities.<\/li>\n<li>Manage quality documentation, including change control processes and approval workflows.<\/li>\n<li>Design and lead strategic quality improvement initiatives and transformation programs in line with business goals.<\/li>\n<li>Monitor and report on quality KPIs monthly, using data to support continuous improvement initiatives.<\/li>\n<\/ul>\n<p>\u00a0<\/p>\n<p><strong>ABOUT ACE HEALTH AB<\/strong><br \/>Fysiologic is part of ACE Health AB, a global leader in cardiac diagnostic services.<br \/>As the market leader in the Netherlands, Fysiologic is known for its expertise and commitment to high-quality cardiac diagnostics.<br \/>With ACE Health AB&#8217;s ongoing growth, we are expanding our capabilities to deliver innovative, fully integrated solutions to healthcare providers worldwide.<br \/>Working at Fysiologic means joining a fast-growing company with international impact and a strong focus on healthcare advancement.<\/p>\n<p><strong>HOW TO APPLY<\/strong><br \/>Are you passionate about regulatory affairs and healthcare, and want to contribute to a leading company in cardiac diagnostics.<br \/>We&#8217;d love to hear from you!<br \/>Click &amp; Apply or send your CV and motivation letter to <a href=\"mailto:info@fysiologic.nl\">info@fysiologic.nl<\/a> .<br \/>Join Fysiologic, where innovation and care come together.<\/p>\n\n<p>\u00a0<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"ob-is-breaking-bad elementor-section elementor-top-section elementor-element elementor-element-a54832b elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"a54832b\" data-element_type=\"section\" 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