- Planning multiple regulatory affairs projects and activities including analysis of situations or data requiring an evaluation of intangible variables with accountability for successful completion within scope of project deliverables
- Representing the regulatory function on manufacturing and product development teams providing input on regulatory requirements, including providing alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also keeps management apprised of alternative actions
- Reviewing and approving protocols, reports, engineering drawings, procedures, labeling and other product development and manufacturing documentation to ensure compliance with regulatory requirements, consistency and accuracy
- Providing direction and guidance to smaller project teams to execute tactical regulatory affairs projects and/or initiatives including preparation and oversight of documentation packages for submission to regulatory agencies
- Tracking timelines and documents for inclusion in regulatory submissions; may interact with regulatory agencies as part of submission review and on-site audit support
- Identifying and evaluating regulatory affairs process improvements and/or course correction/course alignment opportunities
- Developing strategies and contingency plans for projects
- Facilitating Edwards' introduction of proposed and current global regulations and guidance; may advise on impact of such regulations on the company and may implement solutions
- 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
- Reviewing promotional material and labeling content to ensure compliance with regulatory requirements, consistency and accuracy
- Bachelor's Degree AND 5 years previous related experience OR
- Master's Degree AND 3 years related experience
- Experience with strong input/authoring 510(k)s
- Regulatory affairs experience with software devices and product development
- Experience with strong input/authoring 510(k)s
- Regulatory affairs experience with software devices
- Experience with product development
- Experience preparing domestic and international product submissions
- Basic knowledge and understanding of global regulatory requirements for new products or product changes
- Basic knowledge and understanding of domestic and global regulations relevant to Class II and/or Class III medical devices
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Senior Specialist, Regulatory Affairs, Critical Care - Irvine, United States - Edwards Lifesciences Corp
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.
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.
How you will make an impact:
As a Senior Specialist, Regulatory Affairs, you work with other functional areas as the regulatory expert to provide regulatory guidance throughout the R&D and clinical process, for each of our critical care devices in NPD stages.
What you'll need (Required):
What else we look for (Preferred):
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.
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.
