Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex 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.
How you’ll make an impact：
- Support and take some parts of development of accurate and effective clinical studies associated documents and study registration based on leader/manager directions.
- Develop and prepare some parts of clinical reports and associated documentation for successful completion within scope of project deliverables
- Support management of processes to obtain, evaluate and resolve cross-functional input for document finalization for one BU product
- Serve as regulatory and clinical science liaison throughout product lifecycle. Participates in regulatory strategy and clinical science.
- Prepare clinical trial associated documents and evaluation report applications according to government regulations, hospital ethics committee needs, and company requirements for submission.
- Other incidental duties
What you'll need (Required):
Bachelor's Degree in related field, 3 Years’ experience previous related experience Required or Bachelor’s degree in scientific discipline (e.g., Biology, Microbiology, Chemistry) Experience in preparing domestic and international product submissions Preferred
What else we look for (Preferred):
- Proven expertise in MS Office Suite, including Adobe, and ability to operate general office
- machinery
- Written and verbal communication skills including negotiating and relationship management skills
- Problem-solving and critical thinking skills
- Excellent ability to read, write and speak English
- Full knowledge and understanding of Edwards policies, procedures, and global and China medical device regulatory guidelines relevant to clinical protocols
- Understanding of regulatory submissions, reporting, and audits
- Problem-solving and organizational skills
- Ability to manage confidential information with discretion
- Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
- Ability to interact with senior internal and external personnel on significant matters often
- Requiring coordination between organizations Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Skills Required
- Bachelor's Degree in related field
- 3 Years' experience previous related experience
- Experience in preparing domestic and international product submissions
Edwards Lifesciences Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Edwards Lifesciences and has not been reviewed or approved by Edwards Lifesciences.
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Retirement Support — Retirement programs include a 401(k) match complemented by a separate profit‑sharing contribution. These elements add meaningful long‑term value to total compensation.
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Equity Value & Accessibility — An employee stock purchase plan with a discount and look‑back feature, alongside stock awards for eligible roles, provides notable upside. Program expansions indicate continued accessibility.
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Leave & Time Off Breadth — Time‑off policies include generous PTO, company holidays, and a year‑end holiday shutdown. These offerings enhance work‑life support when available at the site.
Edwards Lifesciences Insights
What We Do
Edwards Lifesciences (NYSE: EW), is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more. Our roots date back to 1958 when Miles Lowell Edwards, a retired engineer with a background in hydraulics and fuel pump operations, set out to build the first artificial heart. Edwards believed the heart could be mechanized and was encouraged by Dr. Albert Starr to focus on developing an artificial heart valve. After just two years, the first Starr-Edwards mitral valve was developed and successfully placed in a patient. This innovation spawned Edwards Laboratories. Miles’ fascination with healing the heart and helping patients with heart disease stemmed from his own experience with rheumatic fever as a teenager and continues to fuel our patient-first culture today. Today, we are as passionate about providing innovative solutions for people fighting cardiovascular disease as we have ever been. It's our Credo. It takes integrity, collaboration, innovation, and focus. We are leaders in the design and manufacture of tissue replacement heart valves and repair products as well as advanced hemodynamic monitoring. We partner with physicians to innovate products designed to help patients live longer, healthier, and more productive lives. Our work is both rewarding and a privilege. The importance of what we do defines our approach. We work together to create an environment where ideas can flourish and we provide our people with the resources, expertise and support to bring those ideas to life. For our legal terms and trademarks, please visit: https://www.edwards.com/legal/legal-terms
