Manager, Regulatory Affairs, Critical Care - Edwards Lifesciences
Irvine, CA
About the Job
For over 50 years, the Critical Care business within Edwards Lifesciences (NYSE: EW) has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we’re committed to creating a world where every patient who _should_ be monitored _will_ be monitored with smart technology.
With this impactful vision in mind, we are now embarking on becoming an independent business from Edwards, a process that we currently expect to be completed by January 2025.
As Critical Care transitions to an independent company, we will continue to benefit from the expertise and experience of 4,000+ dedicated global employees, a vibrant innovation engine with strong investment in our future pipeline, and strong sales growth and profitability. We are well-positioned to build upon our category leadership as we continue to launch new solutions powered by A.I. to clinicians, and expand into new care settings.
So, if you're a dynamic and passionate person who is eager to contribute to an innovative, industry-leading advanced monitoring company we invite you to explore our career opportunities. Those who choose to join us will be part of a ‘once-in-a-lifetime’ journey to improve the quality of care and outcomes for millions of patients around the world.
_Appendix:_ For further detail on the spin-off from Edwards Lifesciences, please consult this 2023 Investor Conference Presentation, pages 89-99 (https://ir.edwards.com/events-presentations/event-details/2023/Edwards-Lifesciences-2023-Investor-Conference-2023-bK2BbXaBha/default.aspx) .
How you will make an impact:
As a Manager, Regulatory Affairs, you are responsible for completing and maintaining regulatory approvals and clearances of assigned products.
+ Representing the regulatory function on manufacturing and product development teams as a subject matter expert (SME) to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues; also recommending multiple solutions for selection by management. Preparing formal Regulatory Plans. Reviewing and approving protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance, consistency, and accuracy.
+ Preparing, providing direction and overseeing documentation packages for submission to global regulatory agencies. Preparing GUIDID submission data. Tracking timelines and documenting milestone achievements for inclusion in regulatory submissions. Interacting 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).
+ Providing guidance on regulatory requirements necessary for strategic and contingency planning, including developing regulatory strategic plans and leading teams to implement solutions.
+ Reviewing promotional material, labeling content, product and process changes, and product documentation to ensure regulatory requirements compliance, consistency, and accuracy.
+ Monitoring proposed and current global regulations and guidance; assessing impact of such regulations and guidance on assigned project(s), proposing suggestions on utilizing regulatory updates to expedite approval process
+ Monitoring proposed and current global regulations and guidance; assessing impact of such regulations and guidance on multiple projects, proposing suggestions and leading the implementation on utilizing regulatory updates to expedite approval process.
What you’ll need (Required):
+ Master’s degree and 6 years of previous related experience OR Bachelor’s degree and 8 years of previous related experience
+ Coursework, seminars and/or other formal government and/or trade association training
+ Ability to speak and read Japanese
+ PMDA experience
What else we look for (Preferred):
+ Experience in preparing domestic and international product submissions
+ Extensive knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
+ Extensive knowledge and understanding of global regulatory requirements for new products or product changes.
+ Extensive knowledge of new product development systems
+ Ability to interact with regulatory agencies and international regulatory partners
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, the base pay range for this position is $120,000 to $170,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
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, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
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.
With this impactful vision in mind, we are now embarking on becoming an independent business from Edwards, a process that we currently expect to be completed by January 2025.
As Critical Care transitions to an independent company, we will continue to benefit from the expertise and experience of 4,000+ dedicated global employees, a vibrant innovation engine with strong investment in our future pipeline, and strong sales growth and profitability. We are well-positioned to build upon our category leadership as we continue to launch new solutions powered by A.I. to clinicians, and expand into new care settings.
So, if you're a dynamic and passionate person who is eager to contribute to an innovative, industry-leading advanced monitoring company we invite you to explore our career opportunities. Those who choose to join us will be part of a ‘once-in-a-lifetime’ journey to improve the quality of care and outcomes for millions of patients around the world.
_Appendix:_ For further detail on the spin-off from Edwards Lifesciences, please consult this 2023 Investor Conference Presentation, pages 89-99 (https://ir.edwards.com/events-presentations/event-details/2023/Edwards-Lifesciences-2023-Investor-Conference-2023-bK2BbXaBha/default.aspx) .
How you will make an impact:
As a Manager, Regulatory Affairs, you are responsible for completing and maintaining regulatory approvals and clearances of assigned products.
+ Representing the regulatory function on manufacturing and product development teams as a subject matter expert (SME) to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues; also recommending multiple solutions for selection by management. Preparing formal Regulatory Plans. Reviewing and approving protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance, consistency, and accuracy.
+ Preparing, providing direction and overseeing documentation packages for submission to global regulatory agencies. Preparing GUIDID submission data. Tracking timelines and documenting milestone achievements for inclusion in regulatory submissions. Interacting 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).
+ Providing guidance on regulatory requirements necessary for strategic and contingency planning, including developing regulatory strategic plans and leading teams to implement solutions.
+ Reviewing promotional material, labeling content, product and process changes, and product documentation to ensure regulatory requirements compliance, consistency, and accuracy.
+ Monitoring proposed and current global regulations and guidance; assessing impact of such regulations and guidance on assigned project(s), proposing suggestions on utilizing regulatory updates to expedite approval process
+ Monitoring proposed and current global regulations and guidance; assessing impact of such regulations and guidance on multiple projects, proposing suggestions and leading the implementation on utilizing regulatory updates to expedite approval process.
What you’ll need (Required):
+ Master’s degree and 6 years of previous related experience OR Bachelor’s degree and 8 years of previous related experience
+ Coursework, seminars and/or other formal government and/or trade association training
+ Ability to speak and read Japanese
+ PMDA experience
What else we look for (Preferred):
+ Experience in preparing domestic and international product submissions
+ Extensive knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
+ Extensive knowledge and understanding of global regulatory requirements for new products or product changes.
+ Extensive knowledge of new product development systems
+ Ability to interact with regulatory agencies and international regulatory partners
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, the base pay range for this position is $120,000 to $170,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
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, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
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.
Source : Edwards Lifesciences