Edwards Lifesciences
Manager, Regulatory Affairs Surgical
Edwards Lifesciences, Irvine, California, United States, 92713
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Manager, Regulatory Affairs Surgical
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Edwards Lifesciences 4 days ago Be among the first 25 applicants Join to apply for the
Manager, Regulatory Affairs Surgical
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Edwards Lifesciences Get AI-powered advice on this job and more exclusive features. 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.
Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s 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 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 recommends multiple solutions for selection by management. Prepare formal Regulatory Plans. Review and approve protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance, consistency, and accuracy Prepare, provide direction and oversee documentation packages for submission to global regulatory agencies. Prepare GUIDID submission data. Track timelines and documents milestone achievements for inclusion in regulatory submissions. 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) Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing regulatory strategic plans and leading teams to implement solutions. Review promotional material, labeling content, product and process changes, and product documentation to ensure regulatory requirements compliance, consistency, and accuracy 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 Monitor proposed and current global regulations and guidance; assess impact of such regulations and guidance on multiple projects, propose suggestions and lead the implementation on utilizing regulatory updates to expedite approval process
What you will need (Required):
Bachelor's Degree & a minimum of 8 years related experience Extensive knowledge and understanding of global regulations relevant to Class II and/or Class III medical devices Extensive knowledge of new product development systems
What else we look for (Preferred):
Master's Degree & a minimum of 6 years related experience Experience in preparing domestic and international product submissions
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 $123,000 to $174,000 (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 is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination. Seniority level
Seniority level Not Applicable Employment type
Employment type Full-time Job function
Job function Legal Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Edwards Lifesciences by 2x Get notified about new Regulatory Affairs Manager jobs in
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Medical & Scientific Affairs Project & Operations Manager (ASP)
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Manager, Regulatory Affairs Surgical
role at
Edwards Lifesciences 4 days ago Be among the first 25 applicants Join to apply for the
Manager, Regulatory Affairs Surgical
role at
Edwards Lifesciences Get AI-powered advice on this job and more exclusive features. 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.
Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s 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 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 recommends multiple solutions for selection by management. Prepare formal Regulatory Plans. Review and approve protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance, consistency, and accuracy Prepare, provide direction and oversee documentation packages for submission to global regulatory agencies. Prepare GUIDID submission data. Track timelines and documents milestone achievements for inclusion in regulatory submissions. 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) Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing regulatory strategic plans and leading teams to implement solutions. Review promotional material, labeling content, product and process changes, and product documentation to ensure regulatory requirements compliance, consistency, and accuracy 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 Monitor proposed and current global regulations and guidance; assess impact of such regulations and guidance on multiple projects, propose suggestions and lead the implementation on utilizing regulatory updates to expedite approval process
What you will need (Required):
Bachelor's Degree & a minimum of 8 years related experience Extensive knowledge and understanding of global regulations relevant to Class II and/or Class III medical devices Extensive knowledge of new product development systems
What else we look for (Preferred):
Master's Degree & a minimum of 6 years related experience Experience in preparing domestic and international product submissions
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 $123,000 to $174,000 (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 is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination. Seniority level
Seniority level Not Applicable Employment type
Employment type Full-time Job function
Job function Legal Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Edwards Lifesciences by 2x Get notified about new Regulatory Affairs Manager jobs in
Irvine, CA . Sr. Regulatory Affairs Specialist - SaMD/SiMD
Irvine, CA $83,898.06-$120,000.00 2 weeks ago Irvine, CA $83,898.06-$120,000.00 2 weeks ago Specialist - Premarket Regulatory Affairs
Irvine, CA $110,000.00-$120,000.00 3 months ago Buena Park, CA $140,000.00-$150,000.00 2 weeks ago Manager, Regulatory Affairs (International Regulations) - Biosense Webster, Inc.
Irvine, CA $115,000.00-$197,800.00 6 days ago Associate Director, Global Regulatory Affairs- Soft Tissue Fillers
Irvine, CA $137,500.00-$261,000.00 1 week ago Senior Specialist, Regulatory Affairs THV
Irvine, CA $90,000.00-$127,000.00 1 day ago Regulatory Affairs and Compliance Analyst (Medicare)
Orange, CA $68,015.00-$108,824.00 4 days ago Senior Manager, Regulatory Affairs (Device)
Aliso Viejo, CA $160,000.00-$180,000.00 2 weeks ago Senior Regulatory Affairs Program Lead - Biosense Webster, Inc.
Irvine, CA $105,000.00-$169,050.00 1 week ago Sr. Quality & Regulatory Manager (Korean Bilingual)
City of Industry, CA $70,000.00-$95,000.00 1 week ago Associate Director, Global Regulatory Affairs- Soft Tissue Fillers
East Irvine, CA $137,500.00-$261,000.00 2 weeks ago AI & Data Manager - Life Sciences R&D Regulatory (Pharma)
Irvine, CA $106,500.00-$202,500.00 1 week ago Irvine, CA $72,000.00-$102,000.00 7 hours ago Brea, CA $42,300.00-$63,400.00 2 weeks ago Brea, CA $42,300.00-$63,400.00 7 hours ago Associate Specialist – Premarket Regulatory Affairs
Medical & Scientific Affairs Project & Operations Manager (ASP)
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr