- Creating complex regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; tracking timelines and documenting milestone achievements, developing regulatory strategy, prioritizing strategies/submissions with operating plans as well as ensuring alignment with KOD in countries
- Representing the OUS regulatory function on manufacturing and product development teams to providing input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues, and/or reporting to management
- Providing guidance on strategies and contingency planning with respect to OUS regulatory requirements, including assessing impact of proposed and current global regulations and proposing suggestions for expediting approvals
- Providing guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and review of labeling content and guidance on process improvement projects, based on prior experience and responses from affiliates
- 3 years of previous related experience and Masters degree in related field OR
- 5 years of previous related experience and Bachelor's degree in related field
- Experience with strong input/authoring 510(k)s
- Regulatory affairs experience with software devices and product development
- Experience preparing domestic and international product submissions
- Bachelors and/or Masters degree in scientific discipline
- 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
-
Group Brand Manager, Critical Care
21 hours ago
Edwards Lifesciences Irvine, United StatesJob Description · 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 pat ...
-
Edwards Lifesciences Irvine, United StatesJob Description & Qualifications · The Vice President of Finance, Global Supply Chain will be primarily responsible for providing financial support to the Critical Care Operations Organization. This role will directly report to the SVP of Finance, Global Supply Chain with a dotte ...
-
Senior Brand Manager, Critical Care
5 days ago
Edwards Lifesciences Irvine, United StatesFor 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 ...
-
Senior Brand Manager, Critical Care
1 week ago
Edwards Lifesciences Gruppe Irvine, United StatesWe have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience. · Senior Brand Manager, Critical Care page is loaded · Senior Brand Manager, Critical Care · Apply · locations · USA ...
-
Manager, Regulatory Affairs, Critical Care
1 week ago
Edwards Lifesciences Irvine, United StatesFor 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 ...
-
Senior Brand Manager, Critical Care
1 week ago
Edwards Lifesciences Irvine, United StatesFor 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 ...
-
Pulmonary Critical Care Medicine Specialist
5 days ago
StrongKids Medical Group Irvine, United StatesJob Description · Job DescriptionNewport Mesa Pulmonary Group is seeking a Pulmonary Critical Care Medicine Specialist (MD or DO) for our outpatient clinic in Costa Mesa, California · This position is 100% outpatient with a convenient Monday-Friday 9am-6pm. The schedule is flexib ...
-
Critical Care
2 days ago
Phoenix Medical Staffing Pomona, CA, United StatesICU RN - $4,992 / week 4 12-hour shifts Required: BLS, ACLS, & CA RN license Positions: 8 - bring a friend and receive a bonus Set between the Inland Empire and the San Gabriel Valley in the Pomona Valley, Ponoma is a charming Californian city that ICU, RN, Critical Care, Healthc ...
-
Edwards Lifesciences Irvine, United StatesFor 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_ ...
-
Edwards Lifesciences Irvine, United StatesFor 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_ ...
-
Edwards Lifesciences Irvine, United StatesMake 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 regula ...
-
Edwards Lifesciences Corp Irvine, United StatesFor 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 ...
-
Edwards Lifesciences Irvine, United StatesFor 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 were committed to creating a world whe Regulatory Affairs, Critical C ...
-
Edwards Lifesciences Gruppe Irvine, United StatesWe have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience. · Product Manager, Downstream Marketing, Critical Care page is loaded · Product Manager, Downstream Marketing, Critical ...
-
Orange County Regulatory Affairs Discussion Group (OCRA) Irvine, United StatesSenior Specialist, Regulatory Affairs, Critical Care · Company: · Edwards Lifesciences LLC · Position: · Req-33420 · Location: · Irvine, CA · Posted: · May 13, 2024 · Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs ...
-
Edwards Lifesciences Irvine, United StatesFor 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 ...
-
Critical Care Hospitalist
1 week ago
Children's Health of Orange County Orange, United StatesCritical Care Hospitalist F unctions as a mid-level provider in the management of pediatric intensive care unit (PICU) and sub-acute units patients. Practicing within developed standardized procedures and process protocols, the Critical Care Hospitalist will evaluate, diagnose, t ...
-
Edwards Lifesciences Corporation Irvine, United StatesFor 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 were committed to creating a world whe Regulatory Affairs, Internatio ...
-
Edwards Lifesciences Irvine, United StatesFor 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_ ...
-
VP, Finance Global Supply Chain Critical Care
2 weeks ago
Edwards Lifesciences Irvine, United StatesJob Description & Qualifications · The Vice President of Finance, Global Supply Chain will be primarily responsible for providing financial support to the Critical Care Operations Organization. This role will directly report to the SVP of Finance, Global Supply Chain with a dott ...
Senior Specialist, International Regulatory Affairs, Critical Care - Irvine, United States - Edwards Lifesciences
Description
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
How you will make an impact:
As a Senior Specialist, International Regulatory Affairs, you complete and maintain regulatory approvals and clearances of assigned products.
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.
