- 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., IDE's, PMA's, annual reports, 510(k)'s, STED's 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
- Other incidental duties
- Bachelor's Degree in a related field and 5 years of previous related experience
- Master's Degree in a related field and 3 years of previous related experience
- Coursework, seminar, and/or other formal government and/or trade association training
- Bachelor's or Master's degree in a scientific discipline (e.g., Biology, Microbiology, Chemistry)
- Experience in preparing EU design dossiers or technical files and US 510(k)s
- Full knowledge and understanding of EU and US regulations relevant to medical devices, Class II and/or Class III devices
- Full knowledge and understanding of EU and US requirements for product changes for disposable marketed products (catheters, minimally invasive sensors, pressure monitoring devices, blood management devices)
- Full knowledge of change management systems
- 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
- Strict attention to detail
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Senior Specialist, Regulatory Affairs, Critical Care - Irvine, United States - Orange County Regulatory Affairs Discussion Group (OCRA)
Description
Senior Specialist, Regulatory Affairs, Critical CareCompany:
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 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.
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.
This role can be either an onsite or hybrid role based at Edwards' Irvine campus.Appendix:
For further detail on the spin-off of Critical Care from Edwards Lifesciences, please consult this 2023 Investor Conference Presentation, pages 89-99:
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.
For California, the base pay range for this position is $88,000 to $124,000 (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 Career website.
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