- Create regulatory submissions, for finalization and submission; track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize regulatory activities with operating plans as well as ensuring alignment in assigned countries/area of work (e.g., country clusters, Center of Excellence)
- Partner with BU RA & COE team in the preparation of documents for submissions, including assuring the appropriate forms for all appropriate regulatory bodies.
- Identify and develop moderately complex Regulatory Affairs process improvement initiatives including system enhancements, training, reports and/or dashboards including executing all RA activities in Edwards systems to ensure compliant product distribution.
- Participate in representing the regulatory function on Business Unit regulatory teams to provide input on regulatory requirements, and resolving conflicts between those requirements and development issues, and/or reporting to management.
- Prepare documents for submissions, including assuring the appropriate forms for all appropriate regulatory bodies
- Bachelor's Degree in related field (scientific discipline e.g., Biomedical, Biology etc. preferred) & 2+ 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.
- 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.
Specialist, Regulatory Affairs - Prague, Česká republika - Edwards Lifesciences
Popis
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:
What you'll need (Required):
Please note: this is a temporary role for 1 year contract.
Other opportunities for future career development could arise within Edwards Lifesciences or the upcoming company.
For over 50 years, the Critical Care business within Edwards Lifesciences (NYSE: EW) has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we're committed to creating a world where every patient who should be monitored will be monitored with smart technology.
With this impactful vision in mind, we are now embarking on becoming an independent business from Edwards, a process that we currently expect to be completed by January 2025.
Appendix:
For further detail on the spin-off of Critical Care from Edwards Lifesciences, please consult this 2023 Investor Conference Presentation, pages 89-99:
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:
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.