Edwards Lifesciences
Senior Manager, Regulatory Affairs THV
Edwards Lifesciences, Irvine, California, United States, 92713
Senior Manager Regulatory Affairs
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.
Aortic stenosis impacts millions of people globally, yet it often remains under‑diagnosed and under‑treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life‑changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. 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
Develop and plan multiple regulatory affairs projects and activities including analysis of situations or data requiring an evaluation of intangible variables with accountability for successful completion of all project deliverables. Includes representing the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including providing alternatives for meeting regulatory requirements and resolving complex conflicts between those requirements and development issues. Review and approve protocols, reports, engineering drawings, procedures, labeling and other product development and manufacturing documentation to ensure compliance with regulatory requirements, consistency and accuracy
Identify and evaluate regulatory affairs process improvement and/or course correction/course alignment opportunities to accelerate route to market access in collaboration with key stakeholders
Provide direction and guidance to project teams to execute tactical regulatory affairs projects and/or initiatives. Includes preparation and oversight of larger documentation packages for submission to regulatory agencies. Track timelines and documents for inclusion in regulatory submissions. Interact with regulatory agencies as part of submission review and on‑site audit support
Develop strategies and contingency plans for projects, including those that are most complex and challenging
May anticipate and advise on future regulatory trends and direction, and recommend preemptive approaches for company regulatory compliance
May act as a key member in RA committee (e.g., AdvaMed, standards/committee) and provide input on the development of standards/regulations that affect the Medical Device industry
May review promotional material and labeling content to ensure compliance with regulatory requirements, consistency and accuracy
What you will need (Required)
Bachelor's Degree and a minimum of 10 years related experience or equivalent work experience based on Edwards criteria
Coursework, seminars, and/or other formal government and/or trade association training
New product development experience
What else we look for (Preferred)
Master's Degree and a minimum of 8 years related experience in preparing domestic and international product submissions or equivalent work experience based on Edwards criteria
Experience in preparing domestic and international product submissions
Excellent written and verbal communication skills including negotiating and relationship management skills
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 (US, EU, and Health Canada) for new products or product changes
Full knowledge of new product development systems
Pay and Benefits For California (CA), the base pay range for this position is
$142,000
to
$201,000
(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.
Location Irvine, CA
Equity and Diversity 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.
Job Details
Seniority level: Not applicable
Employment type: Full‑time
Job function: Legal
Industry: Medical Equipment Manufacturing
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Aortic stenosis impacts millions of people globally, yet it often remains under‑diagnosed and under‑treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life‑changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. 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
Develop and plan multiple regulatory affairs projects and activities including analysis of situations or data requiring an evaluation of intangible variables with accountability for successful completion of all project deliverables. Includes representing the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including providing alternatives for meeting regulatory requirements and resolving complex conflicts between those requirements and development issues. Review and approve protocols, reports, engineering drawings, procedures, labeling and other product development and manufacturing documentation to ensure compliance with regulatory requirements, consistency and accuracy
Identify and evaluate regulatory affairs process improvement and/or course correction/course alignment opportunities to accelerate route to market access in collaboration with key stakeholders
Provide direction and guidance to project teams to execute tactical regulatory affairs projects and/or initiatives. Includes preparation and oversight of larger documentation packages for submission to regulatory agencies. Track timelines and documents for inclusion in regulatory submissions. Interact with regulatory agencies as part of submission review and on‑site audit support
Develop strategies and contingency plans for projects, including those that are most complex and challenging
May anticipate and advise on future regulatory trends and direction, and recommend preemptive approaches for company regulatory compliance
May act as a key member in RA committee (e.g., AdvaMed, standards/committee) and provide input on the development of standards/regulations that affect the Medical Device industry
May review promotional material and labeling content to ensure compliance with regulatory requirements, consistency and accuracy
What you will need (Required)
Bachelor's Degree and a minimum of 10 years related experience or equivalent work experience based on Edwards criteria
Coursework, seminars, and/or other formal government and/or trade association training
New product development experience
What else we look for (Preferred)
Master's Degree and a minimum of 8 years related experience in preparing domestic and international product submissions or equivalent work experience based on Edwards criteria
Experience in preparing domestic and international product submissions
Excellent written and verbal communication skills including negotiating and relationship management skills
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 (US, EU, and Health Canada) for new products or product changes
Full knowledge of new product development systems
Pay and Benefits For California (CA), the base pay range for this position is
$142,000
to
$201,000
(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.
Location Irvine, CA
Equity and Diversity 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.
Job Details
Seniority level: Not applicable
Employment type: Full‑time
Job function: Legal
Industry: Medical Equipment Manufacturing
#J-18808-Ljbffr