Edwards Lifesciences Senior Specialist, Regulatory Affairs – Transcathether Mitral and Tricuspid Therapies in Irvine, California
This is an exciting opportunity for an exceptional Regulatory Affairs professional to join a team that is boldly designing transcatheter mitral and tricuspid therapies from the ground up. TMTT is dedicated to solving the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients’ lives.
The Senior Specialist, Regulatory Affairs for TMTT will complete and maintain clinical and commercial regulatory approvals of Class III implantable products in the US, Canada and EU, focused specifically on the paradigm shifting transcatheter valve replacement therapies.
Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also keeps management apprised of alternative actions.
Review and approve protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance, consistency, and accuracy.
Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing the preliminary regulatory strategic plans
Prepare and oversee documentation packages for submission to global regulatory agencies. Assist with GUDID submissions. Track timelines and documents milestone achievements for inclusion in regulatory submissions.
May interact with regulatory agencies as part of submission review and on-site audit support. (e.g., IDE’s, PMA’s, annual reports, 510(k)’s, STED’s and CE marking design dossiers and technical files)
Monitor proposed and current global regulations and guidance; assess impact of such regulations and guidance on assigned project(s), propose suggestions on utilizing regulatory updates to expedite approval process
Review labeling content product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy
Other incidental duties
Education and Experience:
A Bachelor’s degree in a related field is required; a scientific discipline is preferred.
A minimum of five years of related experience is required with a Bachelor’s degree, OR, a minimum of three years of related experience is required with a Master’s degree.
Coursework, seminars, and/or other formal government and/or trade association training is required
Experience preparing domestic and international product submissions for medical device products is preferred
Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
Excellent written and verbal communication skills including negotiating and relationship management skills
Excellent problem-solving, organizational, analytical and critical thinking skills
Full knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
Full knowledge and understanding of global regulatory requirements for new products or product changes.
Full knowledge of new product development systems
Good leadership skills and ability to influence change
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 key contact representing the organization on contracts or projects
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
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
The time is now to join TMTT and shape mitral and tricuspid therapies that will transform treatment. Don’t miss your chance to be part of a dynamic, challenging, and rewarding environment that offers potential for growth and professional advancement for the right candidate.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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.