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Senior Specialist, Regulatory Affairs (Remote, USA or Hybrid) Transcatheter Mitral & Tricuspid Therapies (TMTT)This is an exciting opportunity for an exceptional Regulatory Affairs professional to join a team that is boldly producing transcatheter mitral and tricuspid therapies. TMTT is dedicated to solving the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients’ lives.This position will provide RA support for new product development (NPD) activities of Class III products in the US and EU regions.Key Responsibilities:Represent regulatory affairs on product development and commercialization teams related to TMTT.
Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing regulatory strategic plans to teams for solutions.
Prepare and oversee documentation packages for submission to global regulatory agencies. 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).
Will monitor proposed and current US and EU regulations and guidance, and will advise the impact of such regulations and guidance on the company within the scope of assigned.
Responsible for regulatory review for claims support of promotional material, labeling content, product and process changes, and product documentation.
Able to collaborate and take direction from team leaders, while working with RA management as required.
Additional Regulatory Affairs related projects as assigned
Qualifications:A Bachelor’s degree is required. A science degree is strongly 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
Class II and Class III regulatory affairs experience within the medical device industry is preferred.
Must possess a strong working knowledge of US /EU regulations that affect Class III devices. Experience preparing domestic and international product submissions is preferred
Must have strong English written and verbal communication skills, and have experience working on cross-functional projects.
Strong ability to problem-solve and apply analytical thinking is required
Additional Skills: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
For Colorado Residents Only:Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.The base pay range for this position is $99,000 to $116,000.Additional information can be found through the link below:https://www.edwards.com/careers/benefitsEdwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.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.
Full-time