Edwards Lifesciences Regulatory Affairs Specialist in Prague, Czech Republic
Our corporate activities are growing and we are currently seeking for full-time, office-based experienced Regulatory Affairs Specialist . This person will supports LifeCycle Management including Advertisement of assigned products/countries.
Support the Product life cycle management of new products, product changes and renewals submissions for product applications or country notifications in EMEACLA (EU, Eastern Europe, 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.
Collection of international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that such information is distributed to appropriate personnel.
Perform Regulatory Impact assessment of product change notifications, providing timely and quality information through RA plans.
AssistRA Manager in coordination with RA Headquarter submissions plans alignment to ensure timely documentation deliverables for submissions.
Promotional materials review and approval to ensure compliance with regulatory requirements.
Support RA Manager in monitoring proposed and current regional regulations and guidance, assessing impact of such regulations and guidance on Edwards processes and systems and in proposing suggestions on handling. Support knowledge management initiatives.
Other incidental duties assigned by Leadership
Educatio n and Experience:
Degree level or equivalent in natural sciences
Experience in preparing domestic and international product submissions is required
Preferably 3 years experience in regulatory environment with responsibility for regulatory projects for medical devices
Preferably experience in coursework, seminars, and/or other formal government and/or trade association training
Up to 3 years in preparing international product submissions
Very good English and for some positions Russian and/or French and/or Spanish and/or Portuguese and/or Polish language skills
Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
Good written and verbal communication skills and interpersonal relationship skills
Good problem-solving, organizational, analytical and critical thinking skills
Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
Solid knowledge and understanding of global regulatory requirements for new products or product changes
Solid knowledge of new product development systems
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
Ability to build productive internal/external working relationships
Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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.