Job Information
Edwards Lifesciences Associate Specialist, Regulatory Affairs in Prague, Czech Republic
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 external government and regulatory authorities, and alongside 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.
This includes:
Developing submission plans and Table of Content, pre-bundling " document repository” to deliver quality and timely regulatory documentation for in country filings.
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).
Assist RA Manager in coordination with RA Headquarter submissions plans alignment to ensure timely documentation deliverables for submissions.
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.
Reviewing promotional materials to comply with local regulatory requirements.
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 in related field (scientific discipline e.g., Biomedical, Biology etc. preferred) & 1+ years of working experience in Regulatory Affairs in relevant industry.
Good knowledge and understanding of global regulatory requirements for new products or product changes & experience in preparing domestic/international product submissions.
Proficiency in English
Strict attention to detail, good communication skills and interpersonal relationship skills
Ability to manage competing priorities in a fast-paced environment.
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.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.