Regulatory Affairs Associate III - Transcatheter Heart Valve
Location: Draper Utah
Description: Edwards Lifesciences is presently looking of Regulatory Affairs Associate III - Transcatheter Heart Valve right now, this vacancy will be placed in Utah. More details about this vacancy opportunity please give attention to these descriptions. An outstanding opportunity to be a part of one of the Medical Device Industry’s most groundbreaking technological innovat! ions. Edwards is the only company to gain FDA approval for this revolutionary technology. This business unit is expected to grow exponentially in the next 3 years and this role could be a significant stepping stone in your career. Edwards has a strong pipeline in this space and the regulatory pathway is critical to getting these lifesaving products to our clinicians and patients.
In this role you will be part of a high performing Regulatory Affairs team with the primary responsibilities which include, but are not limited to:
Support multiple product lines in the percutaneous treatment of aortic valve disease
Represent and provide regulatory guidance to manufacturing support teams
Review of product/manufacturing changes and assessment of regulatory impact
Effectively work in a fast-paced environment with the ability to multitask and manage/prioritize the workload
Communicate and, in some cases, coordinate regulatory relat! ed changes and activities to the core teams and Regulatory Tea! m in Irvine, CA
May require preparation of regulatory submissions or associated documentation (US or EU) for Class I, II or III devices
Qualifications
For the Regulatory Affairs Associate III position, we are looking for individuals with 4+ years of experience in Medical Device RA, preferably in Class III devices and with exposure to PMA products.
Required Skills:
Requires a minimum of four years experience in Regulatory Affairs with a BS or BA degree, preferably in a scientific discipline
Experience with Class III devices preferred. Relevant experience includes interventional cardiology, stents, implantable device, catheter delivery systems, orthopedics, cardiac surgery, heart valves or other innovative PMA devices
Must be competent in applying the appropriate global regulatory requirements for new products or product changes for class II and III devices
Must possess a strong working knowledge of US ! regulations that affect Class II and/or Class III devices; and comprehensive knowledge of global regulations
Experience with the requirements for domestic FDA and EU product submissions required
Requires excellent written and verbal communication skills and experience with problem-solving and analytical ability
About Edwards
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs about 8,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that r! eplace or repair a diseased heart valve to creating new technologies th! at monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
Job Function
:
Regulatory Affairs
Primary Location
:
USA-Utah - Draper
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If you were eligible to this vacancy, please email us your resume, with salary requirements and a resume to Edwards Lifesciences.
If you interested on this vacancy just click on the Apply button, you will be redirected to the official website
This vacancy starts available on: Mon, 22 Jul 2013 18:16:25 GMT
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