Edwards Lifesciences
Senior Specialist, Regulatory Affairs TMTT
Edwards Lifesciences, Irvine, California, United States, 92713
Senior Specialist, Regulatory Affairs TMTT
Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients lives. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patients unmet clinical needs. Its our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you will make an impact: 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., IDEs, PMAs, annual reports, 510(k)s, STEDs 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 What you will need (Required): Bachelor's Degree A minimum of 5 years related experience Knowledge & understanding of regulations for Class II and/or Class III devices Ability to travel up to 10% domestically What else we look for (Preferred): Bachelor's Degree in scientific discipline (e.g., Biology, Microbiology, Chemistry) Experience in preparing domestic and international product submissions Full knowledge and understanding of global regulatory requirements for new products or product changes Full knowledge of new product development systems 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. For California (CA), the base pay range for this position is $90,000 to $127,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. Edwards Lifesciences is an equal opportunity employer. We believe that diversity and inclusion are essential to creating an environment where all our employees can grow and thrive. Guided by our values of integrity and service, we are committed to maintaining a culture of inclusivity and belonging by creating a welcoming workplace for people of all backgrounds. Edwards Lifesciences is committed to providing reasonable accommodations and adjustments to individuals with a disability or neurodivergence. If you need an accommodation or adjustment during the application, interview, or hiring process, please see the disability accommodation section below. #J-18808-Ljbffr
Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients lives. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patients unmet clinical needs. Its our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you will make an impact: 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., IDEs, PMAs, annual reports, 510(k)s, STEDs 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 What you will need (Required): Bachelor's Degree A minimum of 5 years related experience Knowledge & understanding of regulations for Class II and/or Class III devices Ability to travel up to 10% domestically What else we look for (Preferred): Bachelor's Degree in scientific discipline (e.g., Biology, Microbiology, Chemistry) Experience in preparing domestic and international product submissions Full knowledge and understanding of global regulatory requirements for new products or product changes Full knowledge of new product development systems 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. For California (CA), the base pay range for this position is $90,000 to $127,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. Edwards Lifesciences is an equal opportunity employer. We believe that diversity and inclusion are essential to creating an environment where all our employees can grow and thrive. Guided by our values of integrity and service, we are committed to maintaining a culture of inclusivity and belonging by creating a welcoming workplace for people of all backgrounds. Edwards Lifesciences is committed to providing reasonable accommodations and adjustments to individuals with a disability or neurodivergence. If you need an accommodation or adjustment during the application, interview, or hiring process, please see the disability accommodation section below. #J-18808-Ljbffr