Associate Specialist, Regulatory Affairs Czech Republic-Prague Full time Req-52016

Job description

Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives. How you’ll make an impact: Support the Product life cycle management of new products, product changes and renewals submissions for product applications or country notifications in EMEACLA (Middle East, Africa, Canada, Latin America) region. Track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize regulatory activities with operating plans as well as ensuring alignment with Key Operation Drivers in assigned countries/area of work (e.g., country clusters, Team). ​Develop routine Regulatory Affairs process improvement initiatives including system enhancements, training, reports and/or dashboards. Participate in providing guidance and feedback to stakeholders on regulatory activities (e.g., strategies, contingency plans, registration requirement). Create regulatory submissions/playbook under close supervision. Provision of documentation or information required for the bids and tenders. Participate in projects as appropriate. Other incidental duties assigned by Leadership. What you'll need (Required): Bachelor’s degree and relevant experience in regulatory affairs, compliance, medical/clinical affairs, data management, analytics, or a related field. Fluent English is required; additional languages are a plus. What else you'll need (Preferred): Strong data management and analytical skills, with confidence working with systems and structured information. Ability to follow established processes accurately, with strong attention to detail, organization, and follow-through. Collaborative, proactive, and support-oriented mindset, with the ability to work effectively across teams and international stakeholders. What is it like to work at Edwards Lifesciences in the Czech Republic? As a global leader in patient-focused medical innovations, we offer rewarding opportunities and exciting challenges in a truly international, dynamic and friendly work environment. We are committed to fostering a diverse and inclusive work environment where all employees can grow, personally and professionally. To achieve this, we offer on-the-job development, training opportunities and the support and guidance provided by dedicated employee groups (the Edwards Network of Women, Edwards Foundation charity team, sustainability activities, and others). Edwards Lifesciences in the Czech Republic also offers the following benefits: Competitive Compensation and Benefits package Flexible working hours, home office possible Pension Plan Risk Life Insurance Virtual Medical Clinic (online access to healthcare) Meal Benefits Service Awards Enhanced Sick Leave Benefits Flexible Benefit Plan (Cafeteria) Employee Stock Purchase Program Employee Assistance Program Comprehensive Wellness Program including onsite gym, Yoga, Pilates or SM System classes, massages, fresh fruit in the office, healthy lifestyle workshops, educational events, charity activities and much more. Benefits are regulated by an internal policy which contains the full details regarding the entitlement and conditions for the benefits. Benefits policy and components may vary by location. . SHARE THIS JOB Job reference Req-52016 Apply Now Type Full time Category Regulatory Affairs Location Czech Republic-Prague Posted for 2 hours ago SHARE THIS JOB Apply Now About Edwards Lifesciences Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. ‌ What we offer Diversity, inclusion & belonging Find out more Our benefits Find out more Edwards Lifesciences is an equal opportunity employer. We believe that diversity and inclusion are essential to creating an environment where all our employees can grow and thrive. Guided by our values of integrity and service, we are committed to maintaining a culture of inclusivity and belonging by creating a welcoming workplace for people of all backgrounds. Edwards Lifesciences is committed to providing reasonable accommodations and adjustments to individuals with a disability or neurodivergence. If you need an accommodation or adjustment during the application, interview, or hiring process, please see the disability accommodation section below.