Our innovative Critical Care business unit seeks a Senior International Regulatory Affairs Manager to oversee Regulatory submissions to all countries outside of the United States and the European Union (including Great Britain). This individual will provide country specific RA input to new product development and manufacturing support teams and ensure that all NPD documentation is provided to the countries on site RA teams per the project plan schedule. The Sr. Manager will track all required recertification’s to ensure that there is no lapse in approvals globally and audit the EU tech files annually to ensure that they are citing the current standards.
Additional Responsibilities will include:
Manage a team of 3+ professionals
Interact with the RA teams in country
As required act as liaison with government
May work on new/emerging technology that has no or limited history
Demonstrate the ability to develop a variety of solutions to regulatory challenges
Work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
Ensure schedules and performance requirements are met. Erroneous decisions will result in critical delay(s) in schedules and/or unit operations and may jeopardize overall business activities.
Requires a minimum of ten years’ experience in Regulatory Affairs. Medical device experience in other areas, may be considered.
Experience in supporting and maintaining international product approvals required.
A Bachelor’s degree is required, preferably in a scientific discipline.
Demonstrated competence in working as part of a focused, project team.
Demonstrated competence in determination of appropriate global regulatory requirements for new products or product changes.
Demonstrated competence in project management skills.
Experience in review and approval of promotional materials is a plus.
Requires familiarity with new product development systems; a working knowledge of all U.S. regulations that affect Class II and Class III devices; a strong working knowledge of global regulations; excellent writing and verbal communication skills; and strong problem-solving and analytical ability.
Ability to work collaboratively in a fast moving highly matrixed organization.
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 ope...rations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 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. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.